Dr. Reddy’s Laboratories announces closure of the transaction to divest ZEMBRACE® SYMTOUCH® and TOSYMRA™ to Upsher-Smith Laboratories, LLC

HYDERABAD, India & PRINCETON, N.J.–(BUSINESS WIRE)–Dr. Reddy’s Laboratories Limited (BSE: 500124, NSE: DRREDDY, NYSE: RDY), announces the closure of the transaction with Upsher-Smith Laboratories, LLC (Upsher-Smith), pursuant to the satisfactory completion of all customary closing conditions including the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act), as amended.

Under the agreement Dr. Reddy’s sold its US and select territory rights for ZEMBRACE® SYMTOUCH® (sumatriptan injection) 3 mg and TOSYMRA (sumatriptan nasal spray) 10 mg, which were commercialized through its wholly owned subsidiary, Promius Pharma, LLC.

COR-0719-359

About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses – Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy’s operates in markets across the globe. Our major markets include – USA, India, Russia & CIS countries, and Europe. For more information, log on to: www.drreddys.com.

About Promius Pharma LLC: Promius Pharma is a wholly-owned subsidiary of Dr. Reddy’s Laboratories, one of the largest and most respected pharmaceutical companies in the world. Promius Pharma is committed to bringing new products to market that meet patients’ needs. For more information, log on to: www.promiuspharma.com.

About Upsher Smith LLC: Upsher-Smith Laboratories, LLC is a trusted U.S. pharmaceutical company that strives to improve the health and lives of patients through an unwavering commitment to high-quality products and sustainable growth. Since 1919, it has brought generics and brands to a wide array of customers backed by an attentive level of service, strong industry relationships, and dedication to uninterrupted supply. For more information, visit www.upsher-smith.com.

Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management’s current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words “may”, “will”, “should”, “expects”, “plans”, “intends”, “anticipates”, “believes”, “estimates”, “predicts”, “potential”, or “continue” and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults , currency exchange rates , interest rates , persistency levels and frequency / severity of insured loss events (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization , including related integration issues.

The company assumes no obligation to update any information contained herein.

Contacts

INVESTOR RELATIONS

AMIT AGARWAL

AMITA@DRREDDYS.COM

(PH: +91-40-4900 2135)

MEDIA RELATIONS

MITALI SARKAR

MITALI.SARKAR@DRREDDYS.COM

(PH: +91-40-4900 2121)

FDA Accepts and Files 22nd Century Group’s Modified Risk Tobacco Product Application for VLN™ Cigarettes

WILLIAMSVILLE, N.Y.–(BUSINESS WIRE)–22nd Century Group, Inc. (NYSE American: XXII), a plant biotechnology company that is a world leader in tobacco harm reduction, announced today that the U.S. Food and Drug Administration (FDA) accepted and filed for substantive scientific review the Company’s Modified Risk Tobacco Product (MRTP) application for its exclusive Very Low Nicotine Content (VLNC) cigarettes under the proposed brand name of VLNTM. 22nd Century’s proposed VLNTM cigarettes are made with the Company’s proprietary VLNC tobacco and, as a result, contain very low levels of nicotine.

“FDA acceptance and filing of our MRTP application marks an important milestone in our mission to reduce the harm caused by smoking,” explained Michael Zercher, Chief Operating Officer of 22nd Century Group. “We look forward to working with FDA as the agency enters the next phase of its review process for our historic application.”

About 22nd Century Group, Inc.

22nd Century is a plant biotechnology company focused on technology which allows it to decrease the level of nicotine in tobacco plants and to modify the level of cannabinoids in hemp/cannabis plants through genetic engineering and modern plant breeding. The Company’s primary mission in tobacco is to reduce the harm caused by smoking. The Company’s primary mission in hemp/cannabis is to develop proprietary hemp/cannabis plants for important new medicines and agricultural crops. Visit www.xxiicentury.com for more information.

Cautionary Note Regarding Forward-Looking Statements: This press release contains forward-looking information, including all statements that are not statements of historical fact regarding the intent, belief or current expectations of 22nd Century Group, Inc., its directors or its officers with respect to the contents of this press release, including but not limited to our future revenue expectations. The words “may,” “would,” “will,” “expect,” “estimate,” “anticipate,” “believe,” “intend” and similar expressions and variations thereof are intended to identify forward-looking statements. We cannot guarantee future results, levels of activity or performance. You should not place undue reliance on these forward-looking statements, which speak only as of the date that they were made. These cautionary statements should be considered with any written or oral forward-looking statements that we may issue in the future. Except as required by applicable law, including the securities laws of the United States, we do not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events or circumstances, or to reflect the occurrence of unanticipated events. You should carefully review and consider the various disclosures made by us in our annual report on Form 10-K for the fiscal year ended December 31, 2018, filed on March 6, 2019, including the section entitled “Risk Factors,” and our other reports filed with the U.S. Securities and Exchange Commission which attempt to advise interested parties of the risks and factors that may affect our business, financial condition, results of operation and cash flows. If one or more of these risks or uncertainties materialize, or if the underlying assumptions prove incorrect, our actual results may vary materially from those expected or projected.

Contacts

22nd Century Group

James Vail, Director of Communications

716-270-1523

jvail@xxiicentury.com

AVROBIO Announces Closing of Underwritten Public Offering and Full Exercise of Underwriters’ Option to Purchase Additional Shares

CAMBRIDGE, Mass.–(BUSINESS WIRE)–AVROBIO, Inc. (NASDAQ: AVRO) (the “Company”), a Phase 2 clinical-stage gene therapy company, today announced the closing of its previously announced underwritten public offering of 7,475,000 shares of its common stock, including 975,000 shares of its common stock pursuant to the underwriters’ exercise in full of their option to purchase additional shares at the public offering price, less underwriting discounts and commissions. The aggregate gross proceeds to the Company from the offering, including the shares sold pursuant to the underwriters’ option, before deducting underwriting discounts and commission and estimated offering expenses, totaled $138.3 million.

Morgan Stanley, Cowen and Wells Fargo Securities acted as joint book-running managers for the offering, Guggenheim Securities acted as lead manager, and Wedbush PacGrow and H.C. Wainwright & Co. acted as co-managers.

The Company intends to use the net proceeds from the offering, in addition to its existing cash resources, to fund the support of the Company’s current programs in Fabry disease, Gaucher disease, cystinosis and Pompe disease, fund external and internal manufacturing and process development activities related to the Company’s programs and to fund research and development activities that relate to all of the Company’s clinical and preclinical activities, including the cost of research and development personnel, and the remainder for planned general and administrative expenses, working capital and other general corporate purposes.

The securities described were offered pursuant to a shelf registration statement on Form S-3 (File No. 333-232489), including a base prospectus. The securities were offered only by means of a prospectus. A final prospectus supplement related to the offering was filed with the Securities and Exchange Commission (SEC) on July 17, 2019 and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus related to this offering may also be obtained by contacting: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014 or Cowen and Company, LLC, Attention: Prospectus Department, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (631) 274-2806.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About AVROBIO, Inc.

AVROBIO, Inc., is a Phase 2 clinical-stage gene therapy company. AVROBIO is focused on the development of its investigational gene therapy, AVR-RD-01, in Fabry disease, as well as additional gene therapy programs in other lysosomal storage disorders including Gaucher disease, cystinosis and Pompe disease.

Forward-Looking Statements

This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will,” and variations of these words or similar expressions that are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements regarding the anticipated use of proceeds from the public offering. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Results in preclinical or early stage clinical trials may not be indicative of results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented.

Any forward-looking statements in this press release are based on AVROBIO’s current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the development of the Company’s product candidates and the use of proceeds from the public offering to support such development. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause AVROBIO’s actual results to differ materially and adversely from those contained in the forward-looking statements, see the section entitled “Risk Factors” in AVROBIO’s Annual Report on Form 10-K for the fiscal year ended December 31, 2018 and our subsequent periodic reports on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in our other filings with the SEC, including those contained or incorporated by reference in the prospectus supplement related to the public offering filed with the SEC. AVROBIO explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

Contacts

Investor Contact:

Christopher F. Brinzey

Westwicke Partners

339-970-2843

chris.brinzey@westwicke.com

Media Contact:

Kathryn Morris

The Yates Network

914-204-6412

kathryn@theyatesnetwork.com

Afya Educacional (NASDAQ:AFYA) Lists on NASDAQ

Brazil’s largest medical education group seeks to transform medical education

NEW YORK–(BUSINESS WIRE)–Today, Afya Educacional (“Afya” or “the Company”), Brazil’s largest medical education group,1 lists on the Nasdaq under the ticker symbol NASDAQ:AFYA. The initial public offering of 13,744,210 Class A common shares is priced at $19.00 per share. Afya is the first company in its industry segment to go public on the Nasdaq, as well as the first Brazilian IPO of 2019 on this exchange.

Afya, a new brand, was formed from the 2019 merger between two leading Brazilian medical education companies. The Company has developed a technology-focused and innovative methodology for medical education, serving learners across undergraduate classes, preparatory courses for residency exams, graduate degrees, and continuing medical education programs.

“Afya’s objective is to be the lifelong educational partner for physicians throughout their learning and professional journey, from undergraduate study through to practice specialization,” says Afya’s CEO, Virgilio Gibbon. “We believe that the medical education market is ripe for disruption. Listing on the Nasdaq underlines our value proposition which is based on three pillars: education, healthcare, and technology. That creates a dynamic for value creation which is very familiar to U.S. investors.”

In the last two years, Afya expanded its healthcare academic offerings through acquisitions. Currently, it has 13 educational centers in five different Brazilian states and a portfolio of preparatory courses for medical residency exams and graduate courses in Brazil’s major cities.

“Although Afya is already the largest medical education operator in Brazil, with over 50 partner hospitals and clinics, the market is still fragmented and offers many opportunities for consolidation,” adds Gibbon. “Our goal is to expand our presence in Brazil through further acquisitions, as well as by partnering with more colleges and hospitals, to further improve the quality of learning, the reach of our courses, and to provide more choices to our medical students.”

GEOGRAPHIC LOCATION

Afya was established in 2019 from the merger of NRE Educacional, the largest group of medical schools in Brazil, and Medcel, a brand of technology-based preparatory courses for medical residency exams. Recently, the Company has broadened its graduate-course portfolio with the acquisition of IPEMED, which offers 13 courses in five capitals: Rio de Janeiro, São Paulo, Brasília, Belo Horizonte and Salvador.

At present, Afya’s portfolio consists of 13 undergraduate units (9 colleges and 4 university centers) in the states of Tocantins (Palmas, Porto Nacional and Araguaína), Minas Gerais (São João del-Rei, Ipatinga, Itajubá, Montes Claros and Sete Lagoas), Piauí (Teresina and Parnaíba), Bahia (Vitória da Conquista and Itabuna) and Paraná (Pato Branco).

Gibbon notes: “Afya Educacional’s geographical presence reflects the Company’s mission. Since its beginning, the founder of NRE, Dr. Nicolau Esteves, had the vision of opening medical schools in small towns with under 5,000 inhabitants that lack adequate health services. After 20 years, it is still incredible to see how we transform the cities where we operate. For instance, every year, we conduct more than 180,000 community outpatient consultations for free.”

DISRUPTING MEDICAL EDUCATION

Afya is a pioneer in using technology to personalize the learning process, delivering content through innovative means. Afya was the first company to release a medical web series completely focused on the teaching-learning process.

“We asked our students how they preferred to learn, and they told us they would like to study in the same that way they watch a TV series,” says Júlio De Angeli, VP Innovation and Continuing Medical Education at Afya. “We created our own series set in a hospital, with 49 real cases linked to the practical experiences of healthcare professionals, tagged and completely integrated into our medical education platform.”

In the next few months, Afya will expand to another four states in Northern and Northeastern Brazil after winning seven new medical schools (five of which are definitive) in Programa Mais Médicos, a federal program to send physicians to neglected areas of the country. The first units will be located in Cruzeiro do Sul (Acre) and Santa Inês (Maranhão), still in 2019. Additional units will be opened in Itacoatiara and Manacapuru (Amazonas) and Cametá (Pará). In each unit, Afya is authorized to offer up to 50 new medical enrollments per year.

AFYA IN NUMBERS

Students: 36,000, of which:

  • 25,000 are undergraduate (6,000 studying medicine)
  • 1,550 in medical graduate courses
  • 9,000 in preparatory courses for medical residency exams, specialist title exams, and specializations

Geographic presence: 19 cities in 8 states

Professors: 2,000, 600 of which are physicians

Administrative employees: 2,000

Courses:

  • Undergraduate: 30
  • Preparatory for residency: 7
  • Continuing Education: 13

ABOUT AFYA EDUCACIONAL

Afya is a leading medical education group in Brazil based on number of medical school seats, delivering an end-to-end physician-centric ecosystem that serves and empowers students to be lifelong medical learners from the moment they join us as medical students through their medical residency preparation, graduation program, and continuing medical education activities.

LEGAL DISCLAIMERS & FORWARD-LOOKING STATEMENTS

This release contains forward-looking statements relating to business prospects, estimates of operating and financial results and growth prospects of Afya. These are merely projections and, as such, are based exclusively on the expectations of Afya’s management. Such forward-looking statements depend, substantially, on external factors, in addition to the risks disclosed in Afya’s filed disclosure documents and are, therefore, subject to change without prior notice.

__________________________

1 By number of admissions authorized by the Ministry of Education (1,352 in total).

Contacts

PRESS

In Press Porter Novelli

Malu Molter – malu.molter@inpresspni.com.br

Phone: +55 11 3323-1574 / +55 11 98999-0049

INVESTOR RELATIONS

Renata Couto – renata.couto@afya.com.br

Phone: +55 31 3515-7500

Rising Pharmaceuticals Announces the U.S. Launch of a Generic Version of Pregabalin Capsules

SADDLEBROOK, N.J.–(BUSINESS WIRE)–Rising Pharmaceuticals, a Rising Pharma Holdings Inc. company, today announced the U.S. launch & commercial shipment of a generic version of Lyrica®, (pregabalin) Capsules, in all eight commercially available strengths (25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, & 300 mg. Pregabalin Capsules had U.S. sales of approximately $5,497 million for the 12 months ending March 2019, according to IMS Health.

Pregabalin Capsules are indicated for management of neuropathic pain associated with diabetic peripheral neuropathy, for the management of postherpetic neuralgia, for adjunctive therapy for the treatment of partial onset seizures in patients 4 years of age and older, for the management of fibromyalgia, and for the management of neuropathic pain associated with spinal cord injury. The product should be taken only as prescribed.

The commercialization of Pregabalin Capsules is one of the largest volume launches for the company this year and will provide a cost effective treatment option for people living with debilitating neuropathic pain conditions,” said Vimal Kavuru, Chief Executive Officer for Rising Pharmaceuticals.

Rising Pharmaceuticals, as the exclusive distributor for its development and manufacturing partner, Laurus Labs Limited, who recently received final approval from the U.S. Food and Drug Administration (FDA) for the Abbreviated New Drug Application (ANDA), will launch the product immediately.

Rising is a leading supplier of generic medicines in the U.S., and the launch of Pregabalin Capsules, adds to the company’s robust and expanding human pharmaceutical franchise.

Rising Pharmaceuticals sells generic prescription products and over-the-counter pharmaceutical products under the Rising label to leading wholesalers, chain drug stores, distributors and mass merchandisers. Currently, Rising has over 125 approved and commercial products in the US market and an additional 82 products pending launch or in development, representing a combined $12.5 billion in addressable market value. At Rising Pharmaceuticals, we continually seek out new opportunities to grow our business through strategic partnerships with developers, manufacturers and distributors under the Rising label.

Contacts

Margie Abrams, Corporate Communications, 210-961-9000

FDA Approves OTEZLA® (apremilast) for the Treatment of Oral Ulcers Associated with Behçet’s Disease

OTEZLA reduced the number and pain of oral ulcers in the 12-week placebo-controlled Phase 3 RELIEF™ study

With this third indication in the U.S., OTEZLA is the first and only treatment approved for oral ulcers associated with Behçet’s Disease

SUMMIT, N.J.–(BUSINESS WIRE)–$CELG #behcets–Celgene Corporation (NASDAQ:CELG) today announced that the U.S. Food and Drug Administration (FDA) has approved OTEZLA® (apremilast) 30 mg twice daily (BID) for the treatment of adult patients with oral ulcers associated with Behçet’s Disease. OTEZLA, an oral, selective inhibitor of phosphodiesterase 4 (PDE4), is the first and only approved treatment option for oral ulcers associated with Behçet’s Disease, a rare, chronic, multisystem inflammatory disease that is difficult to treat.

“Oral ulcers are a recurring and debilitating manifestation that affects nearly everyone living with Behçet’s Disease, and have an important negative impact on the quality of life for these patients,” said Yusuf Yazici, M.D., Clinical Associate Professor, Department of Medicine, New York University Langone Health. “In the clinical trial, OTEZLA demonstrated improvements in measures of oral ulcers at week 12. OTEZLA has the potential to be a needed treatment option for U.S. patients and their physicians, who previously had limited options available.”

Behçet’s Disease, also known as Behçet’s Syndrome, affects approximately 5 in 100,000 people in the U.S.1,2 Oral ulcers, the most common manifestation of Behçet’s Disease occurring in more than 98% of patients, can be painful, disabling and negatively affect quality of life.3

“We are excited to provide the first and only FDA-approved treatment for oral ulcers associated with Behçet’s Disease,” said Terrie Curran, President, Celgene Inflammation & Immunology. “This approval is a reflection of Celgene’s commitment to research in areas of high unmet need, including rare diseases such as Behçet’s Disease. We remain dedicated to further studying OTEZLA and its role in inflammatory conditions.”

The FDA approval was based on efficacy and safety results from the randomized, placebo-controlled, double-blind Phase 3 RELIEF™ study evaluating OTEZLA in 207 adult patients with Behçet’s Disease with active oral ulcers who were previously treated with at least one nonbiologic medication and were candidates for systemic therapy. Results showed OTEZLA 30 mg BID resulted in a 42.7 point reduction from baseline in the pain of oral ulcers as measured by the visual analog scale (VAS) at week 12, compared with an 18.7 point reduction with placebo. The proportion of patients achieving an oral ulcer complete response (oral ulcer-free) at week 12 was 52.9% in the OTEZLA arm and 22.3% in the placebo arm. The proportion of patients achieving oral ulcer complete response by week 6 and who remained oral ulcer-free for at least six additional weeks during the 12-week treatment phase was 29.8% in the OTEZLA arm and 4.9% in the placebo arm. The daily average number of oral ulcers during the 12-week treatment phase was 1.5 in the OTEZLA arm and 2.6 in the placebo arm (based on oral ulcer counts measured at baseline and at weeks 1, 2, 4, 6, 8, 10 and 12).

“Behçet’s Disease is a chronic inflammatory disease in which patients present with symptoms such as oral ulcers that can have a significant impact on daily life,” said Mirta Avila Santos, M.D., Executive Director, American Behçet’s Disease Association. “Today’s approval for OTEZLA marks an important milestone for people with Behçet’s Disease who have been eagerly waiting for treatment options for their oral ulcers.”

The most common adverse events observed occurring in ≥10% of patients in the RELIEF trial were diarrhea (41.3% with OTEZLA; 20.4% for placebo), nausea (19.2% with OTEZLA; 10.7% for placebo), headache (14.4% with OTEZLA; 10.7% for placebo) and upper respiratory tract infection (11.5% with OTEZLA; 4.9% for placebo). The safety profile was consistent with the known safety profile of OTEZLA.

OTEZLA is now approved for three indications in the U.S., including the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, adult patients with active psoriatic arthritis and adult patients with oral ulcers associated with Behçet’s Disease. Since its initial FDA approval in 2014, OTEZLA has been prescribed to more than 250,000 patients with moderate to severe plaque psoriasis or active psoriatic arthritis in the U.S.4

OTEZLA is available in the U.S. and is dispensed through a comprehensive network of specialty pharmacies. For more information about accessing OTEZLA and patient support services (including reimbursement assistance and 24/7 nurse support), doctors and patients can contact OTEZLA® SupportPlus™ at 1-844-4OTEZLA (1-844-468-3952) or visit www.OTEZLA.com for more information.

Celgene anticipates a regulatory decision for OTEZLA in oral ulcers associated with Behçet’s Disease from the Pharmaceuticals and Medical Devices Agency in Japan in the second half of 2019. The Company also submitted a Type II Variation to the Marketing Authorization Application earlier this year seeking approval in the European Union.

About the RELIEF™ Study

The RELIEF™ study is a Phase 3 randomized, placebo-controlled, double-blind study evaluating OTEZLA 30 mg BID in 207 adult patients with Behçet’s Disease with active oral ulcers who were previously treated with at least one nonbiologic medication and were candidates for systemic therapy. This 64-week study was conducted at 53 sites across 10 countries.

In the study, 207 adult patients were randomized 1:1 to receive either OTEZLA 30 mg BID (n=104) or placebo (n=103) for the 12-week placebo-controlled treatment phase. Upon completion of week 12, all patients received OTEZLA for the 52-week active treatment phase. Efficacy was assessed based on the number and pain of oral ulcers, including the daily average number of oral ulcers during the 12-week placebo-controlled treatment phase.

About Behçet’s Disease

Behçet’s Disease is associated with abnormalities of the immune system and inflammation of the blood vessels. Behçet’s Disease is characterized by recurrent oral and genital ulcers, skin lesions, uveitis, arthritis, vascular, central nervous system and gastrointestinal involvement. Oral ulcers are present in more than 98% of Behçet’s Disease patients.

Behçet’s Disease has been classified in the U.S. as a rare or “orphan” disease by the National Institutes of Health. At this time, there are limited approved therapies to treat Behçet’s Disease in the U.S. Prevalence of Behçet’s Disease is highest in the Middle East, Asia and Japan.

About OTEZLA® (apremilast)

OTEZLA® (apremilast) 30 mg tablets is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels, which is thought to indirectly modulate the production of inflammatory mediators. The specific mechanism(s) by which OTEZLA exerts its therapeutic action in patients is not well defined.

U.S. PRESCRIBING INFORMATION

INDICATIONS

Otezla® (apremilast) is indicated for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Otezla is indicated for the treatment of adult patients with active psoriatic arthritis.

Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s Disease.

IMPORTANT SAFETY INFORMATION

Contraindications

Otezla® (apremilast) is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation

Warnings and Precautions

Diarrhea, Nausea and Vomiting: Cases of severe diarrhea, nausea, and vomiting were associated with the use of Otezla. Most events occurred within the first few weeks of treatment. In some cases patients were hospitalized. Patients 65 years of age or older and patients taking medications that can lead to volume depletion or hypotension may be at a higher risk of complications from severe diarrhea, nausea, or vomiting. Monitor patients who are more susceptible to complications of diarrhea or vomiting; advise patients to contact their healthcare provider. Consider Otezla dose reduction or suspension if patients develop severe diarrhea, nausea, or vomiting

Depression: Carefully weigh the risks and benefits of treatment with Otezla for patients with a history of depression and/or suicidal thoughts/behavior, or in patients who develop such symptoms while on Otezla. Patients, caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, and they should contact their healthcare provider if such changes occur

Psoriasis: Treatment with Otezla is associated with an increase in depression. During clinical trials, 1.3% (12/920) of patients reported depression compared to 0.4% (2/506) on placebo. Depression was reported as serious in 0.1% (1/1308) of patients exposed to Otezla, compared to none in placebo-treated patients (0/506). Suicidal behavior was observed in 0.1% (1/1308) of patients on Otezla, compared to 0.2% (1/506) on placebo. One patient treated with Otezla attempted suicide; one patient on placebo committed suicide

Psoriatic Arthritis: Treatment with Otezla is associated with an increase in depression. During clinical trials, 1.0% (10/998) reported depression or depressed mood compared to 0.8% (4/495) treated with placebo. Suicidal ideation and behavior was observed in 0.2% (3/1441) of patients on Otezla, compared to none in placebo-treated patients. Depression was reported as serious in 0.2% (3/1441) of patients exposed to Otezla, compared to none in placebo-treated patients (0/495). Two patients who received placebo committed suicide compared to none on Otezla.

Behçet’s Disease: Treatment with Otezla is associated with an increase in depression. During the clinical trial, 1% (1/104) reported depression or depressed mood compared to 1% (1/103) treated with placebo. No instances of suicidal ideation or behavior were reported in patients treated with Otezla or treated with placebo.

Weight Decrease: Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider discontinuation of Otezla

Psoriasis: Body weight loss of 5-10% occurred in 12% (96/784) of patients treated with Otezla and in 5% (19/382) of patients treated with placebo. Body weight loss of ≥10% occurred in 2% (16/784) of patients treated with Otezla compared to 1% (3/382) of patients treated with placebo

Psoriatic Arthritis: Body weight loss of 5-10% was reported in 10% (49/497) of patients taking Otezla and in 3.3% (16/495) of patients taking placebo.

Behçet’s Disease: Body weight loss of >5% was reported in 4.9% (5/103) of patients taking Otezla and in 3.9% (4/102) of patients taking placebo.

Drug Interactions: Apremilast exposure was decreased when Otezla was co-administered with rifampin, a strong CYP450 enzyme inducer; loss of Otezla efficacy may occur. Concomitant use of Otezla with CYP450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended

Adverse Reactions

Psoriasis: Adverse reactions reported in ≥5% of patients were (Otezla%, placebo%): diarrhea (17, 6), nausea (17, 7), upper respiratory tract infection (9, 6), tension headache (8, 4), and headache (6, 4)

Psoriatic Arthritis: Adverse reactions reported in at least 2% of patients taking Otezla, that occurred at a frequency at least 1% higher than that observed in patients taking placebo, for up to 16 weeks (after the initial 5-day titration), were (Otezla%, placebo%): diarrhea (7.7, 1.6); nausea (8.9, 3.1); headache (5.9, 2.2); upper respiratory tract infection (3.9, 1.8); vomiting (3.2, 0.4); nasopharyngitis (2.6, 1.6); upper abdominal pain (2.0, 0.2)

Behçet’s Disease: Adverse reactions reported in at least ≥5% of patients taking Otezla, that occurred at a frequency at least 1% higher than that observed in patients taking placebo, for up to 12 weeks were (Otezla%, placebo%): diarrhea (41.3, 20.4); nausea (19.2, 10.7); headache (14.4, 10.7); upper respiratory tract infection (11.5, 4.9); upper abdominal pain (8.7, 1.9), vomiting (8.7, 1.9); back pain (7.7, 5.8); viral upper respiratory tract infection (6.7, 4.9); arthralgia (5.8, 2.9).

Use in Specific Populations

Pregnancy: Otezla has not been studied in pregnant women. Advise pregnant women of the potential risk of fetal loss. Consider pregnancy planning and prevention for females of reproductive potential. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Otezla during pregnancy. Information about the registry can be obtained by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/otezla/.

Lactation: There are no data on the presence of apremilast or its metabolites in human milk, the effects of apremilast on the breastfed infant, or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Otezla and any potential adverse effects on the breastfed child from Otezla or from the underlying maternal condition.

Renal Impairment: Otezla dosage should be reduced in patients with severe renal impairment (creatinine clearance less than 30 mL/min); for details, see Dosage and Administration, Section 2, in the Full Prescribing Information.

Please click here for Full Prescribing Information.

About Celgene

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next‐generation solutions in protein homeostasis, immuno‐oncology, epigenetics, immunology and neuro‐inflammation. For more information, please visit www.celgene.com. Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, Facebook and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates,” “plans,” “will,” “outlook” and similar expressions. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in our Annual Report on Form 10-K and our other reports filed with the U.S. Securities and Exchange Commission, including factors related to the proposed transaction between Bristol-Myers Squibb and Celgene, such as, but not limited to, the risks that: management’s time and attention is diverted on transaction related issues; disruption from the transaction make it more difficult to maintain business, contractual and operational relationships; legal proceedings are instituted against Bristol-Myers Squibb, Celgene or the combined company that could delay or prevent the proposed transaction; and Bristol-Myers Squibb, Celgene or the combined company is unable to retain key personnel.

Hyperlinks are provided as a convenience and for informational purposes only. Celgene bears no responsibility for the security or content of external websites.

All trademarks are the property of their respective owners.

###


1 Zeidan MJ, Saadoun D, Garrido M , Klatzmann D, Six A, Cacoub P. Behçet’s disease physiopathology: a contemporary review. Autoimmun Highlights. 2016;7(1):4.

2 Leonardo NM, McNeil J. Behçet’s disease: is there geographical variation? A review far from the Silk Road. Int J Rheumatol. 2015;2015:945262.

3 Medscape EMedicine. Dermatological Aspects of Behcet Disease Clinical Presentation. https://emedicine.medscape.com/article/1122381-clinical. Accessed February 2019.

4 Symphony Health Solution PrescriberSource PatientFocus, Includes all prescriptions from April 2014 through April 2019.

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U.S. Gastro-Intestinal Stromal Tumors Market Report 2019: The Pipeline, Epidemiology, Market Valuations, Drugs (Sales & Market Share), and Competitive Landscape Through 2014-2024 – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “US Gastro-Intestinal Stromal Tumors Market and Competitive Landscape – 2019” report has been added to ResearchAndMarkets.com’s offering.

This report provides comprehensive insights into Gastro-Intestinal Stromal Tumors pipeline products, Gastro-Intestinal Stromal Tumors epidemiology, Gastro-Intestinal Stromal Tumors market valuations and forecast, Gastro-Intestinal Stromal Tumors drugs sales and competitive landscape in the US.

The research is classified into seven sections – Gastro-Intestinal Stromal Tumors treatment options, pipeline products, market analysis comprising of epidemiology, key products marketed, market valuations and forecast, drugs sales and market shares.

Research Scope

  • Gastro-Intestinal Stromal Tumors pipeline: Find out the products in clinical trials for the treatment of Gastro-Intestinal Stromal Tumors by development phase 3, phase 2, and phase 1, by pharmacological class and companies developing the products
  • Gastro-Intestinal Stromal Tumors epidemiology: Find out the number of patients diagnosed (prevalence) with Gastro-Intestinal Stromal Tumors in the US
  • Gastro-Intestinal Stromal Tumors drugs: Identify key products marketed and prescribed for Gastro-Intestinal Stromal Tumors in the US, including trade name, molecule name, and company
  • Gastro-Intestinal Stromal Tumors drugs sales: Find out the sales revenues of Gastro-Intestinal Stromal Tumors drugs in the US
  • Gastro-Intestinal Stromal Tumors market valuations: Find out the market size for Gastro-Intestinal Stromal Tumors drugs in 2018 in the US. Find out how the market advanced from 2014 and forecast to 2024
  • Gastro-Intestinal Stromal Tumors drugs market share: Find out the market shares for key Gastro-Intestinal Stromal Tumors drugs in the US

Benefits of this Research

  • Support monitoring and reporting national Gastro-Intestinal Stromal Tumors market analysis and sales trends
  • Track competitor drugs sales and market share in the US Gastro-Intestinal Stromal Tumors market
  • Track competitive developments in Gastro-Intestinal Stromal Tumors market and present key issues and learnings
  • Synthesize insights for Gastro-Intestinal Stromal Tumors market and products to drive business performance
  • Answer key business questions about the Gastro-Intestinal Stromal Tumors market
  • Evaluate commercial market opportunity assessment, positioning, and segmentation for Gastro-Intestinal Stromal Tumors products
  • Supports decision making in R&D to long term marketing strategies

Key Topics Covered

1) Gastro-Intestinal Stromal Tumors Treatments

2) Gastro-Intestinal Stromal Tumors Pipeline

3) US Gastro-Intestinal Stromal Tumors Epidemiology

4) Marketed Drugs for Gastro-Intestinal Stromal Tumors in US

5) US Gastro-Intestinal Stromal Tumors Market Size and Forecast

6) US Gastro-Intestinal Stromal Tumors Products Sales and Forecast

7) US Gastro-Intestinal Stromal Tumors Market Competitive Landscape

8) Methodology

List of Tables

1. Gastro-Intestinal Stromal Tumors Phase 3 Clinical Trials, 2019

2. Gastro-Intestinal Stromal Tumors Phase 2 Clinical Trials, 2019

3. Gastro-Intestinal Stromal Tumors Phase 1 Clinical Trials, 2019

4. Gastro-Intestinal Stromal Tumors Epidemiology, US, 2014 – 2024

5. Marketed Drugs for Gastro-Intestinal Stromal Tumors, US, 2018

6. Gastro-Intestinal Stromal Tumors Market Size and Forecast ($), US, 2014 – 2024

7. Gastro-Intestinal Stromal Tumors Product Sales ($), US, 2014 – 2024

List of Figures

1. Gastro-Intestinal Stromal Tumors Epidemiology, US, 2014 – 2024

2. Gastro-Intestinal Stromal Tumors Market Size and Forecast ($), US, 2014 – 2024

3. Gastro-Intestinal Stromal Tumors Products Market Share (%), US, 2018

For more information about this report visit https://www.researchandmarkets.com/r/nvi6g7

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com

For E.S.T Office Hours Call 1-917-300-0470

For U.S./CAN Toll Free Call 1-800-526-8630

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Related Topics: Oncology Drugs

United States Pruritus Market Report 2019: The Pipeline, Epidemiology, Market Valuations, Drugs (Sales & Market Share), and Competitive Landscape, 2014-2024 – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “US Pruritus Market and Competitive Landscape – 2019” report has been added to ResearchAndMarkets.com’s offering.

This report provides comprehensive insights into Pruritus pipeline products, Pruritus epidemiology, Pruritus market valuations and forecast, Pruritus drugs sales and competitive landscape in the US.

The research is classified into seven sections – Pruritus treatment options, pipeline products, market analysis comprising of epidemiology, key products marketed, market valuations and forecast, drugs sales and market shares.

Research Scope

  • Pruritus pipeline: Find out the products in clinical trials for the treatment of Pruritus by development phase 3, phase 2, and phase 1, by pharmacological class and companies developing the products
  • Pruritus epidemiology: Find out the number of patients diagnosed (prevalence) with Pruritus in the US
  • Pruritus drugs: Identify key products marketed and prescribed for Pruritus in the US, including trade name, molecule name, and company
  • Pruritus drugs sales: Find out the sales revenues of Pruritus drugs in the US
  • Pruritus market valuations: Find out the market size for Pruritus drugs in 2018 in the US. Find out how the market advanced from 2014 and forecast to 2024
  • Pruritus drugs market share: Find out the market shares for key Pruritus drugs in the US

Benefits of this Research

  • Support monitoring and reporting national Pruritus market analysis and sales trends
  • Track competitor drugs sales and market share in the US Pruritus market
  • Track competitive developments in Pruritus market and present key issues and learnings
  • Synthesize insights for Pruritus market and products to drive business performance
  • Answer key business questions about the Pruritus market
  • Evaluate commercial market opportunity assessment, positioning, and segmentation for Pruritus products
  • Supports decision making in R&D to long term marketing strategies

Key Topics Covered

1) Pruritus Treatments

2) Pruritus Pipeline

3) US Pruritus Epidemiology

4) Marketed Drugs for Pruritus in US

5) US Pruritus Market Size and Forecast

6) US Pruritus Products Sales and Forecast

7) US Pruritus Market Competitive Landscape

8) Methodology

List of Tables

1. Pruritus Phase 3 Clinical Trials, 2019

2. Pruritus Phase 2 Clinical Trials, 2019

3. Pruritus Phase 1 Clinical Trials, 2019

4. Pruritus Epidemiology, US, 2014 – 2024

5. Marketed Drugs for Pruritus, US, 2018

6. Pruritus Market Size and Forecast ($), US, 2014 – 2024

7. Pruritus Product Sales ($), US, 2014 – 2024

List of Figures

1. Pruritus Epidemiology, US, 2014 – 2024

2. Pruritus Market Size and Forecast ($), US, 2014 – 2024

3. Pruritus Products Market Share (%), US, 2018

For more information about this report visit https://www.researchandmarkets.com/r/snjc4s

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com

For E.S.T Office Hours Call 1-917-300-0470

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Related Topics: Dermatological Drugs

United States Uterine Fibroids Market & Competitive Landscape: Analysis & Outlook Through 2014-2024 – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “US Uterine Fibroids Market and Competitive Landscape – 2019” report has been added to ResearchAndMarkets.com’s offering.

This report provides comprehensive insights into Uterine Fibroids pipeline products, Uterine Fibroids epidemiology, Uterine Fibroids market valuations and forecast, Uterine Fibroids drugs sales and competitive landscape in the US.

The research is classified into seven sections – Uterine Fibroids treatment options, pipeline products, market analysis comprising of epidemiology, key products marketed, market valuations and forecast, drugs sales and market shares.

Research Scope

  • Uterine Fibroids pipeline: Find out the products in clinical trials for the treatment of Uterine Fibroids by development phase 3, phase 2, and phase 1, by pharmacological class and companies developing the products
  • Uterine Fibroids epidemiology: Find out the number of patients diagnosed (prevalence) with Uterine Fibroids in the US
  • Uterine Fibroids drugs: Identify key products marketed and prescribed for Uterine Fibroids in the US, including trade name, molecule name, and company
  • Uterine Fibroids drugs sales: Find out the sales revenues of Uterine Fibroids drugs in the US
  • Uterine Fibroids market valuations: Find out the market size for Uterine Fibroids drugs in 2018 in the US. Find out how the market advanced from 2014 and forecast to 2024
  • Uterine Fibroids drugs market share: Find out the market shares for key Uterine Fibroids drugs in the US

Benefits of this Research

  • Support monitoring and reporting national Uterine Fibroids market analysis and sales trends
  • Track competitor drugs sales and market share in the US Uterine Fibroids market
  • Track competitive developments in Uterine Fibroids market and present key issues and learnings
  • Synthesize insights for Uterine Fibroids market and products to drive business performance
  • Answer key business questions about the Uterine Fibroids market
  • Evaluate commercial market opportunity assessment, positioning, and segmentation for Uterine Fibroids products
  • Supports decision making in R&D to long term marketing strategies

Key Topics Covered

1) Uterine Fibroids Treatments

2) Uterine Fibroids Pipeline

3) US Uterine Fibroids Epidemiology

4) Marketed Drugs for Uterine Fibroids in US

5) US Uterine Fibroids Market Size and Forecast

6) US Uterine Fibroids Products Sales and Forecast

7) US Uterine Fibroids Market Competitive Landscape

8) Methodology

List of Tables

1. Uterine Fibroids Phase 3 Clinical Trials, 2019

2. Uterine Fibroids Phase 2 Clinical Trials, 2019

3. Uterine Fibroids Phase 1 Clinical Trials, 2019

4. Uterine Fibroids Epidemiology, US, 2014 – 2024

5. Marketed Drugs for Uterine Fibroids, US, 2018

6. Uterine Fibroids Market Size and Forecast ($), US, 2014 – 2024

7. Uterine Fibroids Product Sales ($), US, 2014 – 2024

List of Figures

1. Uterine Fibroids Epidemiology, US, 2014 – 2024

2. Uterine Fibroids Market Size and Forecast ($), US, 2014 – 2024

3. Uterine Fibroids Products Market Share (%), US, 2018

For more information about this report visit https://www.researchandmarkets.com/r/evmadi

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com

For E.S.T Office Hours Call 1-917-300-0470

For U.S./CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

Related Topics: Women’s Health

United States Wet Age-Related Macular Degeneration Market Report 2019: The Pipeline, Epidemiology, Market Valuations, Drugs (Sales & Market Share), and Competitive Landscape Through 2014-2024 – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “US Wet Age-Related Macular Degeneration Market and Competitive Landscape – 2019” report has been added to ResearchAndMarkets.com’s offering.

This report provides comprehensive insights into Wet Age-Related Macular Degeneration pipeline products, Wet Age-Related Macular Degeneration epidemiology, Wet Age-Related Macular Degeneration market valuations and forecast, Wet Age-Related Macular Degeneration drugs sales and competitive landscape in the US.

The research is classified into seven sections – Wet Age-Related Macular Degeneration treatment options, pipeline products, market analysis comprising of epidemiology, key products marketed, market valuations and forecast, drugs sales and market shares.

Research Scope

  • Wet Age-Related Macular Degeneration pipeline: Find out the products in clinical trials for the treatment of Wet Age-Related Macular Degeneration by development phase 3, phase 2, and phase 1, by pharmacological class and companies developing the products
  • Wet Age-Related Macular Degeneration epidemiology: Find out the number of patients diagnosed (prevalence) with Wet Age-Related Macular Degeneration in the US
  • Wet Age-Related Macular Degeneration drugs: Identify key products marketed and prescribed for Wet Age-Related Macular Degeneration in the US, including trade name, molecule name, and company
  • Wet Age-Related Macular Degeneration drugs sales: Find out the sales revenues of Wet Age-Related Macular Degeneration drugs in the US
  • Wet Age-Related Macular Degeneration market valuations: Find out the market size for Wet Age-Related Macular Degeneration drugs in 2018 in the US. Find out how the market advanced from 2014 and forecast to 2024
  • Wet Age-Related Macular Degeneration drugs market share: Find out the market shares for key Wet Age-Related Macular Degeneration drugs in the US

Benefits of this Research

  • Support monitoring and reporting national Wet Age-Related Macular Degeneration market analysis and sales trends
  • Track competitor drugs sales and market share in the US Wet Age-Related Macular Degeneration market
  • Track competitive developments in Wet Age-Related Macular Degeneration market and present key issues and learnings
  • Synthesize insights for Wet Age-Related Macular Degeneration market and products to drive business performance
  • Answer key business questions about the Wet Age-Related Macular Degeneration market
  • Evaluate commercial market opportunity assessment, positioning, and segmentation for Wet Age-Related Macular Degeneration products
  • Supports decision making in R&D to long term marketing strategies

Key Topics Covered

1) Wet Age-Related Macular Degeneration Treatments

2) Wet Age-Related Macular Degeneration Pipeline

3) US Wet Age-Related Macular Degeneration Epidemiology

4) Marketed Drugs for Wet Age-Related Macular Degeneration in US

5) US Wet Age-Related Macular Degeneration Market Size and Forecast

6) US Wet Age-Related Macular Degeneration Products Sales and Forecast

7) US Wet Age-Related Macular Degeneration Market Competitive Landscape

8) Methodology

List of Tables

1. Wet Age-Related Macular Degeneration Phase 3 Clinical Trials, 2019

2. Wet Age-Related Macular Degeneration Phase 2 Clinical Trials, 2019

3. Wet Age-Related Macular Degeneration Phase 1 Clinical Trials, 2019

4. Wet Age-Related Macular Degeneration Epidemiology, US, 2014 – 2024

5. Marketed Drugs for Wet Age-Related Macular Degeneration, US, 2018

6. Wet Age-Related Macular Degeneration Market Size and Forecast ($), US, 2014 – 2024

7. Wet Age-Related Macular Degeneration Product Sales ($), US, 2014 – 2024

List of Figures

1. Wet Age-Related Macular Degeneration Epidemiology, US, 2014 – 2024

2. Wet Age-Related Macular Degeneration Market Size and Forecast ($), US, 2014 – 2024

3. Wet Age-Related Macular Degeneration Products Market Share (%), US, 2018

For more information about this report visit https://www.researchandmarkets.com/r/pgukce

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com

For E.S.T Office Hours Call 1-917-300-0470

For U.S./CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

Related Topics: Optical Disorders Drugs