Drug Discovery News

BioMarin pledges up to $588M to Merck KGaA in rare-disease land grab

Thu, 01 Oct 2015 15:59:50 +0000

BioMarin Pharmaceutical bet more than half a billion dollars on the rare disease phenylketonuria Thursday. The U.S.-based biotech will pay its development partner Merck KGaA 340 million euros up front for worldwide rights to Kuvan (excluding Japan), plus 60 million euros more in sales-related milestone payments.

Bristol-Myers wins $256K nod for Opdivo-plus-Yervoy in melanoma

Thu, 01 Oct 2015 15:44:30 +0000

Bristol-Myers Squibb continued its immuno-therapy march today with a combo approval in melanoma. The pairing of its older med Yervoy and new PD-1 cancer-fighter Opdivo won the FDA's green light for patients with advanced melanoma and a particular genetic variation.

Teva beefs up in emerging markets with $2.3B Rimsa buyout

Thu, 01 Oct 2015 13:46:42 +0000

Last month, names like Sanofi, Pfizer, Abbott and Takeda were flying around as potential suitors for Mexico-based Representaciones e Investigaciones Medicas, aka Rimsa. But it's Teva that's emerged victorious in the field.

Express Scripts: Strict prior-auth moves keep a tight lid on PCSK9 sales

Thu, 01 Oct 2015 13:46:21 +0000

Turns out, pharmacy benefits managers are doing fine at controlling their costs for the new generation of cholesterol drugs. How? By limiting scripts to patients who are actually eligible for the PCSK9 meds, which carry list prices of more than $14,000.

U.K. patient group demands government override Roche's Kadcyla patents

Thu, 01 Oct 2015 13:33:22 +0000

Roche has been facing pricing pushback for its breast cancer drug Kadcyla in the U.K., with the country's cost watchdog nixing the med last year and the Cancer Drugs Fund recently rejecting it from its covered list. Now, patients are voicing their discontent, calling on Britain's health minister to override the company's Kadcyla patents and open the door for lower-priced copies.

Novartis stacks up more data for lucrative Cosentyx expansion

Thu, 01 Oct 2015 12:59:41 +0000

Novartis is chasing a pair of new uses for brand-new psoriasis med Cosentyx, and when it comes to psoriatic arthritis, it's piling up the positive data.

UPDATED: Novartis falls short in controversial IPR process as board nixes Gilenya patent

Wed, 30 Sep 2015 16:00:23 +0000

The U.S. Patent and Trademark Office's review board has dealt its first blow to Big Pharma. The appeal panel nixed a patent on Novartis' multiple sclerosis blockbuster Gilenya, handing a win to challenger Torrent Pharmaceuticals--and fellow generics makers Mylan and Apotex, which had filed a separate challenge.

Roche poised for MS coup with PhIII success in progressive disease

Wed, 30 Sep 2015 15:35:03 +0000

Roche's experimental therapy, ocrelizumab, recently posted positive Phase III data in patients with primary progressive multiple sclerosis, a less common form of the disease--affecting about 10% to 20% of sufferers--that right now remains untreated.

Merck KGaA counts on Latin America to power consumer-health future

Wed, 30 Sep 2015 15:23:17 +0000

Lately, Latin America has been leading the growth ranks for Merck KGaA's consumer health unit. And that's not set to change anytime soon, its leader says.

Not done yet, Hillary Clinton airs pharma-focused ad starring Turing CEO

Wed, 30 Sep 2015 14:43:42 +0000

Turing Pharmaceuticals CEO Martin Shkreli's 15 minutes of infamy aren't over yet, thanks to presidential candidate Hillary Clinton. In a new campaign ad airing this week, Clinton makes Shkreli the "star," interspersing an image of his face from a Today Show interview with newscast snippets about his outrageous Daraprim price hike--and Clinton's responding proposals, of course.

How can Pradaxa, Xarelto and Eliquis finally unseat warfarin? Safety data, analyst says

Wed, 30 Sep 2015 14:26:20 +0000

New oral anticoagulants--such as Johnson & Johnson's Xarelto and Boehringer Ingelheim's Pradaxa--have been in fierce competition with one another for awhile now. But they still have a ways to go to displace the old-guard therapy warfarin--and one GlobalData analyst thinks she knows why.

New Hampshire AG launches investigation into opioid marketing

Wed, 30 Sep 2015 13:38:10 +0000

Amid growing backlash from state and local lawmakers over opioid marketing, New Hampshire is cracking down on several companies marketing the drugs, claiming that the drugmakers intentionally exaggerated their products' benefits while downplaying serious risks.

Who's most at risk if the U.S. cracks down on prices? Gilead, Celgene top the list

Tue, 29 Sep 2015 15:19:45 +0000

With pharma's U.S. pricing power apparently in jeopardy, industry watchers are worried. Just take a look at drug stocks' performance over the past week or so, as a firestorm over an enormous price increase by one drugmaker--Turing Pharmaceuticals--inspired political promises and public rancor.

UPDATED: Allergan's H2 looks lighter without generics, but 10% growth on tap for 2016

Tue, 29 Sep 2015 14:20:15 +0000

What will Allergan look like after it hives off its generics unit to Teva Pharmaceutical Industries? The company unveiled some new numbers on that score Monday. And while the company's status as a potential top 10 pharma company proved short-lived, it's still looking for a growth rate that outpaces its Big Pharma peers.

Citing cost, top doctors back limits on PCSK9 cholesterol fighters

Tue, 29 Sep 2015 14:19:38 +0000

Payers unhappy with the cost of new PCSK9 drugs are getting some ammo, as top U.S. physicians are recommending against using the drugs in a large patient pool.

Pfizer CEO sees no real future for Clinton's drug-pricing proposals

Tue, 29 Sep 2015 12:55:39 +0000

Pfizer CEO Ian Read isn't too worried about proposals to crack down on U.S. drug pricing. Presidential candidate Hillary Clinton's slate of new measures--which include negotiating power for Medicare--aren't likely to pass muster in Congress, Read told Evercore ISI analyst Mark Schoenebaum.

UPDATED: Sorry, Celgene, patent board says. Bass can challenge your IP, and profit, too

Mon, 28 Sep 2015 19:40:34 +0000

Drugmakers that have been attacked by patent challenger Kyle Bass would like nothing more than to see him stopped in his tracks by the U.S. Patent and Trademark Office, a move that would also prevent other investment firms from following in his footsteps. But as the Patent Trial and Appeal Board announced on Friday, it's not going to happen.

Shkreli-shaming spills over onto Valeant as Dems call CEO to account for price hikes

Mon, 28 Sep 2015 19:02:19 +0000

After the outpouring of rage that greeted Turing Pharmaceuticals last week when it decided to hike the price on an older med by 5000%-plus, its CEO, Martin Shkreli, is one of the last people any pharma chief would want to be compared with right now. But that's the position Valeant skipper J. Michael Pearson found himself in Monday afternoon.

Don't count Merck's Keytruda out in lung cancer fight with BMS' Opdivo

Mon, 28 Sep 2015 15:56:39 +0000

Industry watchers largely expect Bristol-Myers Squibb's Opdivo to come out on top in the checkpoint inhibitor battle. But don't count out Merck's Keytruda, even if it winds up with a narrower label, analysts say.

Sanofi patent deal lets Lilly roll out a Lantus biosim in U.S. next December

Mon, 28 Sep 2015 15:37:03 +0000

Sanofi has put off one biosimilar threat to Lantus till the end of 2016. In a patent settlement announced on Monday, the French drugmaker and U.S.-based Eli Lilly & Co. agreed to a royalty deal covering Lantus SoloStar, the injectable pen version of Sanofi's basal insulin.

Houston Biotech DNAtrix Partners With Merck on Brain Cancer Treatment

Thu, 01 Oct 2015 14:58:42 +0000

Houston-based DNAtrix is using a relatively quotidian tool to treat brain cancer: the common cold virus. And today the biotech says it has enlisted some big firepower to help it develop its drug candidate, the pharmaceutical giant Merck. The two companies will collaborate in phase II clinical trials on a therapy to treat glioblastoma, an especially deadly cancer for which there is no cure.

DNAtrix’s drug, DNX-2401, will be paired with pembrolizumab (Keytruda), one of the new “checkpoint inhibitor” drugs that are currently the source of much excitement in the anti-cancer-drug industry. The drugs will be part of a clinical study of fewer than 50 patients with glioblastoma, the most aggressive form of brain cancer and for which there is no cure.

Frank Tufaro, DNAtrix’s CEO, says the trials will be conducted in several sites across the country following about a six-month period to recruit patients. “We’re allowing up to two years to get all the data in,” he says.

DNAtrix was founded in 2005, and raised $5 million in 2009 and $20 million in 2014 in Series A and B rounds, respectively, from investors such as Houston-based Mercury Fund and Morningside.

In phase 1 clinical trials of its drug that started in 2009, Tufaro said that, for example, three patients who were treated at the University of Texas M.D. Anderson Cancer Center in Houston, saw their tumors completely disappear. “We saw an improvement in overall survival,” he adds. “We hope to cure everyone but, the initial diagnosis is so bad, that we’re looking for improvement in overall survival right now.”

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Elcelyx Raises $40M, Begins Late-Stage Trial of New Diabetes Drug

Thu, 01 Oct 2015 12:34:32 +0000

San Diego-based Elcelyx Therapeutics said today it has secured $40 million in a Series E financing—its biggest ever—after receiving official guidance from the FDA for late-stage trials of its oral drug candidate, a delayed-release formulation of metformin.

Elcelyx is targeting the 40 percent of patients with type 2 diabetes who can’t tolerate existing formulations of metformin, a first-line drug of choice for most of them.

In an interview with Xconomy earlier this year, Elcelyx CEO Alain Baron laid out three options for funding late-stage clinical trials: raise capital through an IPO; sell Elcelyx to a big pharma; or raise enough funding for Elcelyx to carry out the late-stage trials itself. With today’s announcement, it appears the company is pursuing a low-budget version of option No. 3.

At that time, Baron estimated it would cost $100 million to complete three late-stage studies that would involve a total of 1,500 to 2,000 patients.

In a statement today, Elcelyx said the $40 million it raised from two new investors, Hong Kong’s Sailing Capital and certain funds managed by Boston’s Clough Capital Partners, along with all existing investors, would support the first of those three late-stage studies. Elcelyx, founded in 2010, previously secured about $57 million from Morganthaler Ventures, Kleiner Perkins Caufield & Byers, Technology Partners, and GSM Fund.

Between 7 million and 8 million Americans with type 2 diabetes can’t take standard metformin, either because of adverse side effects that include severe nausea, vomiting, and diarrhea, or because the patients’ impaired kidney function leads to a condition known as metformin-associated lactic acidosis. The delayed-release formulation developed by Elceylx targets the lower bowel, which limits the absorption of metformin into the blood. The company said it provides the benefits of metformin without the systemic exposure-related health risks posed to patients with kidney impairment.

Elcelyx said it already has begun the first study, a phase 2b dose-ranging study designed to document Metformin DR’s potential for use by patients with impaired kidney function or gastrointestinal difficulties. The company plans to enroll about 550 patients in the study.

According to Elcelyx, the trial would likely be followed by two pivotal late-stage studies, one of which would include type 2 diabetes patients with moderate renal impairment. Elcelyx did not indicate how those studies would be funded, however.

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Chemical Industry Wants U.N. Effort To Stay Focused On Original Goal

nobody@acs.org("Cheryl Hogue") — Tue, 29 Sep 2015 20:34:00 +0000

Safety: Industry wants U.N. to stick to safe management of bulk chemicals, not expand to hazardous pesticides or persistent drugs

Statin Drugs Could Help Patients With Duchenne Muscular Dystrophy

nobody@acs.org("Michael Torrice") — Mon, 28 Sep 2015 20:09:00 +0000

Drug Discovery: Cholesterol-lowering compounds improve muscle function in mice with the disease

Small Molecule Tames Gut Pathogen C. Difficile Rather Than Killing It

nobody@acs.org("Michael Torrice") — Thu, 24 Sep 2015 14:30:00 +0000

Drug Discovery: Mouse experiments show that compound inactivates toxin produced by bacteria responsible for stubborn hospital-acquired infections

Modified Tobacco Plant Helps Make The Anticancer Drug Etoposide

nobody@acs.org("Celia Henry Arnaud") — Mon, 14 Sep 2015 19:45:00 +0000

Plant Biology: Researchers identify enzymes needed for plant to pump out drug precursor

Plant Used In Traditional Mayan Medicine Holds Potential Leishmaniasis Treatment

nobody@acs.org("Deirdre Lockwood") — Fri, 11 Sep 2015 17:39:00 +0000

Drug Discovery: Researchers synthesize a natural product with activity against visceral leishmaniasis

Prices Rise For Priority Vouchers

nobody@acs.org("Ann M. Thayer") — Fri, 11 Sep 2015 01:13:00 +0000

Pharmaceuticals: Big pharma is paying more to get chits from neglected disease firms to speed up FDA review

Redesigning Drugs For Better Breakdown In The Environment

nobody@acs.org("Deirdre Lockwood") — Fri, 04 Sep 2015 21:01:23 +0000

Environment: Researchers fine-tune a common cardiovascular drug to improve its biodegradability in wastewater

Former Police Officer At NIST Pleads Guilty To Attempting Meth Manufacture At Federal Lab

nobody@acs.org("Cheryl Hogue") — Fri, 21 Aug 2015 20:00:00 +0000

Security: Explosion came from “shake and bake” method of making illicit drug

U.S. Food & Drug Administration Approves First 3-D Printed Drug

nobody@acs.org("Jessica Morrison") — Thu, 13 Aug 2015 05:00:00 +0000

Pharmaceuticals: Epilepsy pill easier to swallow, company says

Shire Guns For Baxalta

nobody@acs.org("Lisa M. Jarvis") — Thu, 13 Aug 2015 04:15:00 +0000

Pharmaceuticals: Unsolicited bid is designed to create a rare diseases powerhouse

Invasive Millipede Harbors Speedy Catalyst

nobody@acs.org("Sarah Everts") — Tue, 11 Aug 2015 19:51:13 +0000

Biotechnology: A millipede enzyme makes valuable chiral building blocks for pharmaceuticals faster than its industrial counterparts

U.S. Food & Drug Administration Approves First 3-D Printed Drug

nobody@acs.org("Jessica Morrison") — Wed, 05 Aug 2015 18:51:00 +0000

Pharmaceuticals: Epilepsy pill easier to swallow, company says

Shire Goes After Baxalta

nobody@acs.org("Lisa M. Jarvis") — Tue, 04 Aug 2015 21:06:20 +0000

Pharmaceuticals: Hostile bid is designed to create a rare diseases powerhouse

New Target For Rett Syndrome

nobody@acs.org("Michael Torrice") — Fri, 31 Jul 2015 00:31:51 +0000

Drug Development: Inhibiting phosphatase improves disease symptoms in mice

Teva Will Acquire Allergan’s Generics Business

nobody@acs.org("Michael McCoy") — Mon, 27 Jul 2015 20:48:50 +0000

Pharmaceuticals: $40.5 billion deal will create a top-10 drugmaker

Murky Results For Alzheimer’s Drugs

nobody@acs.org("Lisa M. Jarvis") — Mon, 27 Jul 2015 12:15:00 +0000

Pharmaceuticals: Biogen and Eli Lilly & Co. each offer lukewarm new data on key amyloid-busting antibodies

Appeals Court Greenlights Sales Of Zarxio, The First FDA-Approved Biosimilar Drug

nobody@acs.org("William G. Schulz") — Thu, 23 Jul 2015 21:00:00 +0000

Biologics: But the clock has not run out on possible patent infringement suits by Amgen, developer of the originator drug, Neupogen

Compound Being Tested Against Cancer Also Suppresses HIV In Mice

nobody@acs.org("Judith Lavelle") — Thu, 16 Jul 2015 23:45:03 +0000

Drug Discovery: New approach is the first to block transcription of HIV genes

Celgene Will Pay $7.2 Billion For Receptos

nobody@acs.org("Lisa M. Jarvis") — Thu, 16 Jul 2015 12:00:00 +0000

Biotech: Deal adds key late-stage drug to company’s immunology portfolio

China Stock Rout Hits Chemical Firms

nobody@acs.org("Jean-François Tremblay") — Fri, 10 Jul 2015 14:47:03 +0000

Finance: Makers of drugs and chemicals are caught in a selling frenzy

Allergan Steps Up Acquistions

nobody@acs.org("Ann M. Thayer") — Wed, 08 Jul 2015 13:00:00 +0000

Pharmaceuticals: Post-megamerger, Irish specialty drug firm enters deals for migraine and other drugs