Comfortable that the product candidate's development is in good hands, Enanta Pharmaceuticals (ENTA +6.9%) declines to exercise its co-development option with AbbVie (ABBV +1.9%) for ABT-493, Enanta's next-generation protease inhibitor for hepatitis C. It will be eligible for certain regulatory approval milestones as well as royalties on net sales.
Enanta reaches agreement with AbbVie on the net sales allocations for royalty calculations for ABT-450-containing regimens as well as those containing ABT-493. For the former, the percentage of annual net sales used to calculate Enanta's royalties is 30% and for the latter it is 45%.
Enanta will use its resources to advance its internal HCV candidates, including the NS5A program.
Janssen Research & Development (JNJ +0.5%) strategic partner Pharmacyclics (PCYC +2.3%) submits an sNDA to the FDA for Imbruvica (ibrutinib) for the treatment of Waldenstrom's macroglobulinemia (WM), a rare type of B-cell lymphoma with no treatment options in the U.S. If approved, it will be the fourth indication for the product.
In data presented at the European Association of Nuclear Medicine Congress in Sweden, Progenics Pharmaceuticals' (PGNX +2.6%) imaging agent candidate, 1404, demonstrated enhanced results in a Phase 2 trial focused on prostate cancer imaging.
Imaging with 104 showed 94% sensitivity in detecting and imaging cancer in the prostate gland of high-risk patients prior to prostatectomy. It was more sensitive than MRI in detecting primary prostate cancer (94% vs. 86%) and was a good predictor of lymph node involvement at the time of prostatectomy. SPECT/CT imaging with 1404 identified 14 (19%) more patients with suspicious lymph node sites than MRI.
The uptake of 1404 in the lobes of the prostate showed a statistically significant correlation with Gleason score (p<0.0001).
AstraZeneca (AZN +0.2%) and Bristol-Myers Squibb (BMY +0.3%) win an appeal of an 11-year old whistleblower lawsuit accusing the companies of paying kickbacks to a medical benefits management firm in exchange for purchases and recommendations of drugs they manufacture.
The suit was dismissed because the complaint filed by a former employee of the benefits manager did not satisfy the federal False Claims Act's requirement that the whistleblower be the original source of allegations of wrongdoing. The employee, Karl Schumann, sued the companies on behalf of the U.S. and 11 states alleging the firms paid kickbacks to Medco Health Solutions to buy and recommend their brand name drugs. Mr. Schumann sat in meetings at Medco but had no direct independent knowledge of the scheme. His knowledge came from reviewing documents and discussing them with colleagues who were involved.
The U.S. declined to participate in the suit after a six-year investigation.
Santa Barbara, CA-based Sientra (Pending:SIEN) is set for its IPO of 5M shares of common stock at $14 - 16.
The medical aesthetics company sells a variety of implants to plastic surgeons, including tissue expanders as well as body contouring and facial implants. Its primary products are silicone breast implants, offered in over 120 variations in size, shape and texture.
The collapse of Abbvie's (ABBV +0.6%) planned takeover of Shire plc (SHPG +2.4%) opens a door for Allergan (AGN +2%) to fend off the hostile bid from Valeant (VRX +2.2%). Institutional shareholder Paulson & Co., which owns stakes in both firms, favors the marriage.
Allergan CEO David Pyott received a call from Shire last week. If a deal gets done it will make Allergan too expensive for Valeant to acquire. The chances of a deal appear reasonable. Allergan contacted Shire about a combination some time ago.
Advaxis (ADXS -3%) appoints David J. Mauro, M.D., Ph.D, as EVP, Chief Medical Officer. He will oversee the firm's clinical immuno-oncology programs that utilize Listeria monocytogenes to inhibit tumor growth.
Dr. Mauro joins the company from Merck where he was Executive Director, Section Head Oncology Clinical Development.
Therapix Bio (OTCQB:THXBY) appoints Jan Turek as CEO. He joins the company from the consulting firm TCG LLC where he was a senior strategy and transaction advisor. Previously, he was CEO of Biolex Therapeutics.
The BOD of Cubist Pharmaceuticals (CBST +1.2%) appoints President and COO Robert J. Perez as Chief Executive replacing the retiring Michael W. Bonney. Mr. Perez was appointed COO in 2007 and President in 2012.