Merck snags rights to Endocyte’s ovarian cancer drug in $1B deal

Posted under Blog, Companies, companion diagnostics, Diagnostics, EC145, Endocyte, Funding, Medical Devices, Medical Supply, Merck, ovarian cancer, Partnering, personalized medicine, Pharmaceuticals, Startups, Universities, Videos by john

Merck has scooped up worldwide rights to Endocyte's ($ECYT) late-stage ovarian cancer drug in a billion-dollar deal, paying $120 million upfront and committing up to $880 million in milestones. And West Lafayette, IN-based Endocyte will also get co-promotion rights and a split of U.S. profits while earning double-digit royalties in the rest of the world.

Investors liked the sound of big round numbers, bidding up Endocyte shares by 111% once the news hit.

Merck ($MRK) says the drug--Vintafolide, or EC145--matches the profile of what it's looking for in a cancer drug, highlighting Endocyte's development of a companion diagnostic to identify patients most likely to respond to the treatment. And Endocyte says it's only months away from filing for U.S. approval. The treatment has been given orphan drug status in Europe.

Endocyte's strategy is to use an imaging agent, EC20, to identify patients whose tumors express folate receptors. Those patients who test positive are treated with EC145, which combines a chemotherapy with a conjugate that includes vitamin folate, targeting specific cancer cells. That approach has produced positive results in mid-stage studies, with folate receptor-positive patients achieving a median 5.5 month PFS rate compared to a control arm's 1.5 months.

"Vintafolide is a promising and innovative late-stage cancer drug candidate. In addition to pursuing the lead indication of platinum-resistant ovarian cancer, Merck plans to further evaluate its potential for treatment of multiple other cancer types," said Peter S. Kim, executive vice president and president at Merck Research Laboratories. "This agreement underscores our strategy of building a portfolio of oncology therapeutics that employ a companion diagnostic to facilitate selection of those patients most likely to respond to treatment."

- here's the press release

Special Report: Endocyte - Fierce's 5 Drug Delivery Companies to Watch

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EntreMed lands $10M deal to fund cancer drug trials

Posted under Blog, Companies, Diagnostics, EntreMed, Funding, kinase, leukemia, Medical Devices, Medical Supply, ovarian cancer, Pharmaceuticals, Startups, Universities, Videos by Ryan McBride

EntreMed ($ENMD) has struck a deal to bring in much-needed capital to support development of its experimental kinase inhibitor for attacking multiple types of cancer. And the Rockville, MD-based drug developer could name an interim chief executive to fill a spot vacated three years ago when former CEO Jim Burns left the firm, the Washington Business Journal reported.

The company's latest funding plan, which is subject to shareholder approval, comes in the form of a convertible notes offering, with buyers including IDG-Accel China Growth Fund II, Emerging Technology Partners, and Dr. Tak W. Mak, director of The Campbell Family Institute for Cancer Research.

With the funding, the company has high hopes to advance its lead drug, ENMD-2076, an Aurora A/angiogenic kinase inhibitor in midstage trials to treat ovarian cancer. The drug is also being investigated in initial trials for patients with solid tumors, multiple myeloma and leukemia, the company said. In October, the company's shares jumped on upbeat Phase II data, which showed that 22% of 64 patients with ovarian tumors who took ENMD-2076 lived for 6 months without their cancer getting worse.

"We are very pleased to have the support from a group of knowledgeable investors and the validation of the potential of ENMD-2076. The proceeds from the notes will allow the company to accelerate and expand its research and development activities, fund additional trials, initiatives and long term strategic plans," Michael Tarnow, the company's executive chairman, said in a statement.

- here's the Washington Business Journal's article
- and the company's release

Related Article:
EntreMed shares spike on PhII cancer data

AZ commits $140M to cancer pact as it inks back-to-back deals

Posted under Astellas, AstraZeneca, Blog, Chi-Med, China, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, olaparib, ovarian cancer, Pharmaceuticals, Startups, Type 2 Diabetes, Universities, Videos by John Carroll

A day after AstraZeneca ($AZN) managed to raise fresh doubts about its ability to efficiently develop new therapies with twin setbacks in the clinic, the pharma company is back with a pair of new pipeline pacts. The pharma giant paid $20 million upfront and pledged up to $120 million in milestones for the rights to develop a preclinical cancer treatment discovered in China. And it snagged an option on a pair of diabetes drugs in Astellas' pipeline.

AstraZeneca's deal with Chi-Med revolves around volitinib (HMPL-504), an inhibitor of the c-Met receptor tyrosine kinase, now slated to begin a near-term Phase I study. And AstraZeneca highlighted the role Chinese investigators will play in the development of the treatment. "Volitinib represents a highly attractive global opportunity for AstraZeneca as we seek to develop and commercialise novel, targeted cancer therapies," says Susan Galbraith, head of AstraZeneca's Oncology Innovative Medicines. "This collaboration with HMP represents our commitment to China and brings together two groups with highly complementary capabilities."

AstraZeneca simultaneously completed an option deal with Japan's Astellas for the acquisition of PSN821, a mid-stage treatment, and the pre-clinical PSN842--both for type 2 diabetes. The drugs are oral G protein-coupled receptor GPR119 agonists, "a potential new class of medicines for diabetes." There's no word on exactly how much AstraZeneca is paying for the option to buy the drugs.

Neither of these deals are likely to compensate for the demise of AstraZeneca's ovarian cancer study for olaparib or the news yesterday that the second Phase III study of TC-5214 proved a bust, just like the first one. Olaparib was in Phase II for ovarian cancer when investigators decided to scuttle the program. And TC-5214 was one of the late-stage prospects that AstraZeneca needed to generate fresh revenue.

- read the release on the Chi-Med deal
- here's the release on the pact with Astellas

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AstraZeneca buries one program as second drug stumbles again in PhIII

Posted under antidepressant, AstraZeneca, Blog, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, olaparib, ovarian cancer, Pharmaceuticals, Startups, Targacept, TC-5214, Universities, Videos by John Carroll

AstraZeneca ($AZN) has back-to-back setbacks to report on a pair of key drug development programs. The pharma giant reported that it's burying the ovarian cancer drug program for olaparib after concluding that a mid-stage trial failure made it impossible for investigators to push ahead to the next stage. And investigators had more bad news to report to AstraZeneca and Targacept ($TRGT) about TC-5214, their partnered drug for depression. The treatment flunked its second of four Phase III trials, signaling some deep trouble for a treatment AstraZeneca promised to pay up to $1.24 billion for in their pact.

Those trial woes prompted AstraZeneca to add a $381.5 million impairment charge to its fourth quarter numbers, with $96.5 million of that representing the rapidly dwindling chance of success for the anti-depressant.

The trial failures mark another setback for the development execs at AstraZeneca, who have been struggling to overcome a lackluster record in the clinic. And it's another major blow to Targacept, which already had to deal with the departure of GlaxoSmithKline ($GSK) in the biggest biopharma deal breakup of 2011. Targacept's already battered shares fell 27% this morning.

"AstraZeneca seems to have had more than its fair share of misfortune when it comes to the development pipeline," Barclays Capital noted. "Additional development failures increase the probability that management will reassess the likely return on investment from additional R&D investment and cut costs further."

As in the first Phase III study, TC-5214 could not beat out a placebo in treating depression. Their target measure was a change in the Montgomery-Asberg Depression Rating Scale total score after eight weeks of treatment with TC-5214 as compared to placebo.

Back in 2009 olaparib, a PARP inhibitor, had been one of the stars of the ASCO show, as investigators unveiled significant tumor shrinkage. And the pharma giant isn't giving up on either program. Olaparib will be studied in other cancers while the TC-5214 treatment still has two other late-stage studies to complete.

- read the press release
- here's the Bloomberg report
- get the Dow Jones story

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