WOODCLIFF LAKE, N.J., Sept. 28 /PRNewswire-FirstCall/ - Par Pharmaceutical Companies, Inc. today announced its commitment to developing and marketing novel prescription drugs, through the establishment and introduction of Strativa Pharmaceuticals, its proprietary specialty pharmaceuticals division. Strativa Pharmaceuticals will provide the company’s existing proprietary products division with a unique and recognizable identity in the marketplace -- to both healthcare providers and payers, as well as potential partners.
“Par has a long tradition of developing, manufacturing and marketing high-quality pharmaceuticals,” said Patrick G. LePore, chairman, chief executive officer and president of Par. “Our Generics Division is a leader among U.S. generic drug companies, and we envision Strativa becoming a preeminent specialty pharmaceutical company. Strativa’s unique focus will be to bring innovative proprietary pharmaceuticals to market. We consider this approach the best way to serve the needs of patients, while addressing unmet medical needs.”
Strativa’s current focus is on supportive care products for patients who are often critically ill. These therapeutics help patients manage complications from their illnesses or from the treatments they are receiving for those illnesses. Strativa’s initial product offerings will be in HIV and oncology.
“Strativa is committed to providing treatment options to patients and their healthcare providers,” said John A. MacPhee, president of Strativa Pharmaceuticals. “Our proprietary organization combines the energy and innovation of a new venture with the experience and resources of a leading, diversified pharmaceutical company, enabling us to create value for partners, investors, physicians and patients in an underserved market.”
The branded division -- now Strativa -- launched its first product, Megace(R) ES, in July 2005. Megace ES (megestrol acetate) oral suspension is indicated for anorexia (loss of appetite), cachexia (severe malnutrition), and/or an unexplained, significant weight loss in patients with acquired immunodeficiency syndrome (AIDS). Megace ES generated more than $19 million in net sales in the second quarter of 2007. Megace ES sales are currently annualizing at over $75 million.
Strativa currently also has three Phase III in-licensed supportive care drugs in its pipeline:
-- Zensana(TM) (ondansetron HCl) (with Hana Biosciences, Inc) is being studied for the prevention of nausea and vomiting after chemotherapy, radiation and surgery. Following approval, Zensana is expected to be the first anti-emetic therapy available in an oral spray form. -- Loramyc(TM) (miconazole Lauriad(R)) (with BioAlliance Pharma) is an antifungal therapy currently in Phase III development for the treatment of oropharyngeal candidiasis, an opportunistic infection commonly found in immunocompromised patients, including those with cancer and HIV. -- Pafuramidine maleate, (with Immtech Pharmaceuticals), also in Phase III, is a novel anti-microbial drug being studied for the treatment of pneumocystis pneumonia (PCP) in AIDS patients. Immtech and Strativa may also collaborate to develop pafuramidine as a preventative therapy for patients at risk of developing PCP, including those living with HIV, cancer and other immunosuppressive conditions.
Important Safety Information
Some people may experience side effects associated with Megace ES that include impotence, passing gas, rash, high blood pressure, fever, decreased libido, insomnia, upset stomach, and elevated blood sugar. Women may have breakthrough bleeding during their menstrual cycle.
You should not take Megace ES if you are hypersensitive to megestrol acetate or any component of the formulation. Do not take Megace ES if you are pregnant, suspect that you are pregnant, or are nursing. If you become pregnant while taking this medication, tell your healthcare provider immediately. Women who may become pregnant should be certain to use contraception while taking Megace ES.
Reports on new onset diabetes, worsening of pre-existing diabetes, overt Cushing’s Syndrome (which may be characterized by weight gain in the midsection or upper back, rounding of the face, weakness, fatigue, high blood pressure and bruising), and adrenal insufficiency (which may be characterized by low blood pressure, upset stomach, vomiting, dizziness, or weakness) have been associated with chronic use of megestrol acetate.
Be sure to tell your healthcare provider if you experience any side effects while taking Megace ES.
About Strativa
Strativa Pharmaceuticals is the proprietary products division of Par Pharmaceutical, Inc. Supported by Par’s financial and organizational capabilities including substantial cash resources, Strativa Pharmaceuticals is committed to developing and marketing novel prescription drugs. Its initial focus is on supportive care therapeutics in HIV and oncology. Drawing on the specialty products expertise of its staff, Strativa possesses the resources to prepare products for introduction and to help ensure their success after launch. For additional information, please visit www.strativapharma.com
About Par
Par Pharmaceutical, Inc. develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets. For press release and other company information, visit www.parpharm.com.
Safe Harbor Statement
Certain statements in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this news release contain information that is not historical, these statements are essentially forward-looking and as such, are subject to risks and uncertainties, including the extent and impact of litigation arising out of the accounting issue described in this and prior public announcements, including the lawsuit brought against the company by the trustee for the company’s Senior Subordinated Convertible Notes seeking an accelerated payment of the $200 million of principal of and accrued interest on the notes or, in the alternative, damages, the difficulty of predicting FDA filings and approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, uncertainty of patent litigation filed against the company, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks and uncertainties detailed from time to time in the company’s filings with the Securities and Exchange Commission (SEC), such as the company’s reports on Form 10-K, Form 10-Q, and Form 8-K, and amendments thereto. The company can make no assurance as to the potential effects of the restatement, including the effects of any investigations, informal or otherwise, conducted by the SEC, or other entities, or lawsuits filed against the company in connection therewith. Any forward-looking statements included in this press release are made as of the date here of only, based on information available to the company as of the date hereof, and, subject to any applicable law to the contrary, the company assumes no obligation to update any forward-looking statements.
Contact: Suzanne Beckmann Hill & Knowlton suzanne.beckmann@hillandknowlton.com 212-885-0608
Strativa Pharmaceuticals
CONTACT: Suzanne Beckmann, of Hill & Knowlton, +1-212-885-0608,suzanne.beckmann@hillandknowlton.com
