Industry News

Egalet Corporation, a fully integrated specialty pharmaceutical company focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions, announced the company has submitted a new drug application (NDA) for ARYMO ER (morphine sulfate) extended-release tablets for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate. The submission is based on the pivotal pharmacokinetic studies that demonstrated bioequivalence of ARYMO ER 15 mg, 30 mg and 60 mg to equivalent doses of MS Contin (morphine sulfate controlled-release). In addition, the submission includes a comprehensive battery of abuse-deterrent studies (Category 1, 2 and 3) which were conducted to support abuse-deterrent label claims for intravenous injection, snorting and oral abuse.

Merck, known as MSD outside the United States and Canada, announced  that the U.S. Food and Drug Administration (FDA) approved an expanded age indication for GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant), Merck’s 9-valent human papillomavirus (HPV) vaccine, to now include use in males 16 through 26 years of age, for the prevention of anal cancer caused by HPV types 16, 18, 31, 33, 45, 52 and 58, precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58, and genital warts caused by HPV types 6 and 11. GARDASIL 9 is already approved for use in boys 9 through 15 years of age for the prevention of these diseases. GARDASIL 9 is also approved for use in girls and young women 9 through 26 years of age for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV 16, 18, 31, 33, 45, 52 and 58, precancerous or dysplastic lesions caused by HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58, and genital warts caused by HPV types 6 and 11. GARDASIL 9 is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant].

ViiV Healthcare, a global specialist HIV company with GSK, Pfizer Inc. and Shionogi Limited as shareholders, today announced it has agreed to purchase Bristol-Myers Squibb’s late stage HIV R&D assets. In a separate deal, ViiV Healthcare has agreed to acquire Bristol-Myers Squibb’s HIV portfolio of pre-clinical and discovery stage research assets. Each deal is subject to clearance by the regulatory authorities and is expected to complete in early 2016.

Sanofi and Boehringer Ingelheim have entered into exclusive negotiations to swap businesses. The proposed transaction would consist of an exchange of Sanofi animal health business (Merial) with an enterprise value of €11.4 billion and Boehringer Ingelheim consumer healthcare (CHC) business with an enterprise value of €6.7 billion. Boehringer Ingelheim CHC business in China would be excluded from the transaction. The transaction would also include a gross cash payment from Boehringer Ingelheim to Sanofi of €4.7 billion.

Egalet Corporation, a fully integrated specialty pharmaceutical company focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions, today announced a collaboration agreement with Teva Pharmaceutical Industries Ltd. ("Teva"), a leading global pharmaceutical company. With this agreement, Egalet granted Teva exclusive marketing and commercialization rights to SPRIX (ketorolac tromethamine) Nasal Spray in Israel, Gaza and the West Bank. Teva, a leader in the commercialization of central nervous system (CNS) products, including many in pain management, will be responsible for registering, marketing, distributing and selling SPRIX Nasal Spray in these territories. Under the terms of the agreement, Egalet will receive an undisclosed upfront payment, sales-based milestones and will share in the profits from net sales of SPRIX in these territories. 

Natco Pharma Limited  announced that it has received approval for the generic version of ledipasvir+sofosbuvir combination from Drugs Controller General (India). NATCO plans to launch this combination drug immediately, under its brand name Hepcinat LP, and through its strategic partners in India.

Matinas BioPharma Holding Inc., a clinical-stage biopharmaceutical company focused on identifying and developing safe and effective therapeutics for the treatment of serious and life-threatening infections, today announced that the U.S. Food and Drug Administration (FDA) has designated the Company's lead antibacterial development candidate, MAT2501, as a Qualified Infectious Disease Product (QIDP) for the treatment of non-tuberculous mycobacterium (NTM) infections.

Antares Pharma, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for 4 mg/0.5 mL and 6 mg/0.5 mL Sumatriptan Injection USP in adults for the acute treatment of migraine and cluster headache when a clear diagnosis has been established. The reference listed drug in the ANDA was GlaxoSmithKline’s Imitrex® Injection. Sumatriptan Injection USP represents the Company’s first ANDA approval of a complex generic and second product approved using the VIBEX® auto injector platform. In accordance with our previously disclosed agreement, Teva Pharmaceutical Industries, Ltd. (Teva) will distribute the product through their U.S. generic division and share the profits equally with Antares Pharma.

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