国际新闻精选周二（2017年2月14日）

Inovio and ApolloBio to Collaborate on Development and Commercialization of HPV Pre-cancer Immunotherapy VGX-3100 in Greater China

Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that it has entered into a collaboration and license agreement providing ApolloBio Corporation (NEEQ:430187) with the exclusive right to develop and commercialize VGX-3100, Inovio’s DNA immunotherapy product designed to treat pre-cancers caused by human papillomavirus (HPV), within Greater China (China, Hong Kong, Macao, Taiwan). The agreement provides for potential inclusion of the Republic of Korea three years following the effective date.【阅读全文】

VenBio slams timing, terms of Immunomedics’ $2B deal

VenBio has criticized the timing and terms of Immunomedics’ licensing deal with Seattle Genetics. The investment fund has accused Immunomedics of rushing through a “poorly constructed deal” to sway shareholder opinion ahead of the upcoming fight for control of the biotech’s board.

Immunomedics is set to pocket $250 million upfront and up to $2 billion in total in exchange for the rights to IMMU-132, a solid tumor antibody-drug conjugate (ADC) that is closing in on a filing for FDA approval in triple-negative breast cancer. The Immunomedics management team hailed the deal as validation of their efforts and the company’s share price rose 22%. But venBio, which has bought a 9.9% stake in Immunomedics and is agitating for change, is unimpressed.【阅读全文】

MabVax Therapeutics Studies Lead Investigational Drug MVT-5873 with Halozyme PEGPH20

MabVax Therapeutics Holdings, Inc. (NASDAQ: MBVX), a clinical stage immuno-oncology drug development company, today announced results from a pre-clinical study evaluating the potential benefits of using MabVax's HuMab-5B1antibody, MVT-5873, currently in Phase I clinical trials for the treatment of metastatic pancreatic cancer with Halozyme Therapeutic's (NASDAQ: HALO) investigational drug PEGPH20, which targets the tumor microenvironment potentially allowing increased access of co-administered cancer drug therapies to solid tumors. PEGPH20 is currently in phase III clinical development for metastatic pancreatic cancer and in phase I clinical trials for non-small cell lung cancer, gastric cancer, and metastatic breast cancer.【阅读全文】

Stada receives 3.6 billion euro offer from private equity group Cinven: FT

German generic drugmaker Stada <STAGn.DE> has received a 3.6 billion euro ($3.83 billion) takeover offer from private equity group Cinven, the Financial Times reported.

Cinven's offer follows a year-long activist campaign to improve Stada's profitability by Active Ownership Capital, one of its largest shareholders, and is believed to be pitched at close to 58 euros a share, the Financial Times reported, citing sources.

Cinven declined to comment. Stada was not immediately available to comment.【阅读全文】

Sanofi Agrees to Sell Five Over-the-Counter Drugs to Ipsen

Sanofi agreed to sell some over-the-counter products to Ipsen SA as it edges closer to completing a 22.8 billion-euro ($24.2 billion) asset swap with Boehringer Ingelheim GmbH. Ipsen will pay 83 million euros for five products including Prontalgine, a painkiller, the Paris-based company said in a statement Monday. Bloomberg previously reported the deal was close, citing a person familiar with the situation. French drugmaker Ipsen emerged as the preferred bidder after a competitive sale process involving other pharmaceutical companies, the person said. Ipsen said it expects to complete the purchase in the second quarter. In August, the European Commission approved the proposed acquisition of Boehringer.【阅读全文】

Senator says drugmakers may be misusing FDA orphan drug rules—and costing taxpayers money

Have drugmakers misused a decades-old law designed to spur research into rare, neglected diseases? Sen. Chuck Grassley says he aims to find out. The frequent pharma critic says he's investigating whether “unanticipated uses” of the Orphan Drug Act have helped boost U.S. drug prices.

Last month, Kaiser Health News published a report showing that pharma companies are legally using the Orphan Drug Act to win years of additional brand exclusivity for mass market meds. Drugmakers reapply for approvals in rare diseases, and, if successful, those green lights come with seven years of exclusive access to markets, along with other financial incentives.【阅读全文】

Early win means phase 3 test is on the way for Axovant's dementia drug

Positive results in a first crop of patients treated with its dementia drug have encouraged Axovant to start preparing for a phase 3 study.

So far 11 patients with Lewy body dementia (LBD) have been treated with nelotanserin, which is being developed to tackle the visual hallucinations and sleep disturbances that can afflict people with these diseases.

The results have outpaced expectations, with nelotanserin achieving a significant improvement in extrapyramidal symptoms—Parkinson's disease-like effects caused by the nerve degeneration in LBD—as measured by the Unified Parkinson's Disease Rating Scale (UPDRS), said the biotech.【阅读全文】

Cold Spring Harbor scientists discover protein driver of prostate, lung cancer

A protein called PTEN is often called an “anticancer” protein, because it prevents tumor cells from growing out of control. Mutations in the gene that encodes PTEN are commonly found in prostate cancer, lung cancer and other tumor types. But some patients with abnormally low levels of PTEN don’t carry any mutations in that gene—raising the question of what may be causing the protective protein to break down in those people.【阅读全文】

Ferring strikes pact to use Foresee controlled-release tech

Ferring Pharmaceuticals has struck a deal with Foresee Pharmaceuticals. The agreement will see Ferring fund development of a long-duration peptide drug based on Foresee’s delivery technology and potentially pick up the resulting asset if it meets expectations.

Foresee has landed the deal on the strength of its stabilized injectable formulation (SIF) platform, a technology the Taiwanese drugmaker developed to enable controlled-release delivery of peptides, small molecules and proteins. Ferring penned a deal to use the technology to create a formulation of an as-yet-unidentified peptide after assessing the progress made by Foresee to date.【阅读全文】

Sage Therapeutics Lifts Investor Spirits With Sliver of Depression Drug Data

Sage Therapeutics (SAGE) treated 13 patients suffering from depression with an experimental drug known as SAGE-217. After two weeks, 11 of the patients saw their depressive symptoms cut in half. In eight patients, their depression went into complete remission.

The sliver of new data, announced Monday, show enough potential to advance SAGE-217 into a placebo-controlled mid-stage study in patients with a major depressive disorder, the company said.【阅读全文】

Aviragen Therapeutics slammed again by its second trial failure in days, this time for their lead drug

In back-to-back setbacks, Aviragen Therapeutics $AVIR says that its lead drug vapendavir flunked a Phase IIb in moderate to severe asthmatics with a rhinovirus infection.

Neither of the two doses in the study – 264 mg or 528 mg – achieved a statistically significant outcome on the primary endpoint.

Just days ago in a Q2 call CEO Joseph Patti called this drug the biotech’s most advanced anti-viral.【阅读全文】

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