GILEAD After years of controversial refraining, official India reversed course and granted Gilead Sciences its patent rights to Sovaldi hepatitis C treatment. More than a victory for Gilead, it was the prevalence of fairness after years of underestimating the power to fairness to keep resurfacing until reinstated. The Indian Patent Office had rejected Gilead’s patent application based on a notion that it did not demonstrate …

By June, which is next month, Incyte (INCY) will be the owner of the European operations of Ariad (ARIA). That’s what both firms have announced yesterday. Among other details, the firms decided on signing a licensing agreement for exclusive development and commercialization rights to Ariad’s Iclusig (ponatinib) in the European Union and 22 other countries, including Switzerland, Norway, Turkey, Israel and Russia. Iclusig is approved …

EXELIXIS AGAIN They said: Sell EXEL, as no partner is interested in the firm’s FDA approved cabozantinib to date. What really happened: It did not take long for IPSEN to come forward and take the responsibility of marketing cabozantinib abroad and pay $200 million upfront payment to Exelixis. They said: Although the FDA approved Cabometyx (cabozantinib) for advanced renal cell carcinoma (RCC), the drug will …

Prohost Letter #395 On the Road TO DEFEATING CANCER - Results of cancer treatment with novel immunotherapy drugs suggest that the hope of conquering cancer has improved from doubtful to conceivable. Immunotherapy treatments are scoring unprecedented successes against a wide variety of malignancies, including liquid cancers, solid cancers, cancers with DNA mutations caused by viruses and other cancer-causing agents. The two Immunotherapy approaches are currently occupying …

GILEAD SCIENCES The people who cause the selloff of Gilead’s (GILD) stock because it missed 5 cents are the same who continue to complain about the high price of its HCV drug. This is intriguing because those who advocated selling the stock said that the reason for the miss is the huge discounts the firm is making on the drug price. Gilead is the undisputed …

Medivation is a Target for Acquisition The Question is: Who Will Acquire Medivation? Sanofi has made a bid to acquire Medivation for $9.3 billion (£6.37B). Sanofi is expected to pay $52.50 per share in cash for Medivation. Why Medivation? Sanofi's chief executive Olivier Brandicourt said, "Thanks to Medivation's excellent prostate cancer treatments, we believe that a merger with Medivation would benefit patients and, at the same time, create value …

Biotech NEWS   AGENUS Agenus’ First Checkpoint Inhibitor to reach Clinical Trial The first patient has been dosed in Agenus (AGEN) Phase 1 clinical trial of its checkpoint inhibitor product AGEN1884. The open-label, multicenter trial in patients with advanced or refractory cancer is designed to evaluate the safety of AGEN1884 and determine the estimated maximum tolerated dose. AGEN1884 is an anti-CTLA-4 (cytotoxic T-lymphocyte antigen-4) checkpoint …

Congratulations.   The FDA approved Exelixis’ (EXEL) drug Cabometyx™ (cabozantinib) tablets for advanced renal cell carcinoma (RCC) patients who have received prior anti-angiogenic therapy. RCC is the most common form of kidney cancer in adults. Cabometrix is the first drug to demonstrate robust and clinically meaningful improvements in a phase 3 trial in patients with advanced RCC. The drug satisfied all key efficacy parameters — …

The AACR 2016 meeting presentations differed substantially from previous meetings. The  2016 meeting has brought near certainty that, indeed, defeating cancer is a reachable objective. The road is lengthy, but the speed in analyzing the data and acting upon them towards improvement is unprecedented. You will find the most important information about the AACR cancer meeting in the upcoming Prohost Letter. In the NEWS TAPIMMUNE …

Illumina Showing 6% revenue increase over the same quarter last year, Q1 2016, was not enough as Illumina (ILMN) missed analysts’ expectations and its own projections regarding its revenues. Prior to the announcement of its Q1 results, the giant gene sequencing firm offered investors a comprehensive explanation of the origin of the miss and the actions it has already begun to take to avoid future misses. Illumina pinpointed …

Meaningful Presentations at the Annual Meeting of the American Association for Cancer Research (AACR) NEKTAR THERAPEUTICS NKTR-214 Drug Improves Survival and Extends Immunity in cancer Immunotherapy Nektar Therapeutics (NKTR) investigational immune-stimulatory cytokine therapy NKTR-214 is in Phase 1/2 trial. At the Annual Meeting of the American Association for Cancer Research (AACR) meeting, Nektar announced new preclinical data for NKTR-214, which demonstrate both its activity as a single-agent and its synergistic activity with checkpoint blockade. …

In the biotech sector, daily stories (news) are not just announced, but mostly edited in ways that project the narrators’ tendencies and wishes rather than the original news. Last week’s headlines comprised positive news from a firm’s drug aimed at treating a chronic progressive disease, muscular dystrophy, which disables children’s by weakening their voluntary and involuntary muscles, while threatening their hearts and lungs and lives. Other headlines …

Pursuing its goal in treating hepatitis, Gilead Sciences (GILD) is at the finish line of clinical trials on another virus, this time the Hepatitis B virus. HBV not HCV. Two large Phase 3 trials evaluating once-daily tenofovir alafenamide (TAF) 25 mg in treatment-naïve and treatment-experienced adults with HBeAg-negative and HBeAg-positive chronic hepatitis B virus (HBV) infection met the primary endpoints of non-inferiority to Gilead’s Viread® (tenofovir disoproxil fumarate (TDF) 300 mg.  …

Juno Therapeutics (JUNO) is due to receive a fee payment of $50 million from Celgene. The reason for this compensation is that Celgene has exercised its option to develop and commercialize Juno CD19 program outside North America and China. From now on, Juno will share with Celgene the global development expenses for products in the CD19 program outside the U.S. and china and Celgene will have pay …

Regeneron and Intellia to Discover and Develop CRISPR/Cas Therapeutics Moving forward is Regeneron Pharmaceuticals’ (REGN) strategy based on strong scientific and technological capability that needs no validation by external validators. The quality, i.e., safety and efficacy, of Regeneron’s approved products and the clinical trial outcomes of the firm’s drugs in late phase trials speak for themselves. Good news from the firm is flooding the media. The most recent …

Dealing With Bacterial Resistance To Antibiotics    In the NEWS THERAVANCE BIOPHARMA At the 26th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), Theravance Biopharma (TBPH) demonstrated that its drug Vibativ® (televancin) possesses a potent in vitro activity against broad range of Staphylococcus aureus (S. aureus) clinical isolates. These isolates included Methicillin-resistant S. aureus (MRSA). The antibiotic activity for VIBATIV was seen in 100% of the evaluated S. aureus clinical isolates regardless of their type or resistance …

Another day, another badly needed treatment for a dangerous disease is on its way to be FDA approved. The day was yesterday, Thursday, April 7, 2016. The company is Intercept (ICPT), the disease is primary biliary cirrhosis renamed primary biliary cholangitis (PBC), the drug is called Ocaliva™ (obeticholic acid). The good news came from the FDA's Gastrointestinal Drugs Advisory Committee, which voted 17 to 0to recommend accelerated approval of Ocaliva™.    Now …

Years ago, a friend who is a highly regarded Immunologist lectured us during one of our visits to his home city Milano in Italy about the important role well written press releases play in highlighting the prominence of unknown, yet, capable biotech firms. “If not for its announced news, millions of interested people around the world, including myself, wouldn’t have heard on time about Genentech …

Pfizer (PF) terminated its acquisition agreement with Allergan Plc (AGN) The new set of rules released by the U.S. Treasury Department to make it difficult for U.S. companies to conduct tax inversions contributed Pfizer’s decision. Analysts noted that the new regulations seem almost directly aimed at Pfizer-Allergan. In one of two major parts of the new rules, the U.S. government would not consider the assets acquired …

PFIZER Pfizer (PF) announced that its oral drug tofacitinib in doses of 5 mg and 10 mg twice daily  met Phase 3 endpoints on psoriatic arthritis. The trial was conducted on adult patients with active psoriatic arthritis (PsA). The recruited patients had an inadequate response to at least one conventional anti-rheumatic drug (csDMARD) and were tumor necrosis factor inhibitor (TNFi)-naïve. Patients enrolled in the study were …