From what I can tell, the company is working on the holy grail of in silico drug discovery. Add some inputs, out comes the list of compounds to synthesize. I work for a company that relies heavily on structure activity relationships between virtual molecules and receptor models and all I can say is… good luck.

Numerate Completes $4 Million Financing
-(Via Business Wire Health News.)

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Interesting play here. There is no doubt obesity is a huge and underserved market but one of the reasons is that the treatment therapies must be extremely safe (search CB1 antagonists or rimbonant if you’re in the mood for some light reading).

My question is this: how do you restrict vessel remodeling /angiogenesis (or whatever they’re doing) to just adipose tissue? I would imagine most molecular pathways involved in regulating this network are pretty homogenous across organ systems; no one is suggesting Avastin (VEGF inhibitor) be used for the treatment of obesity for instance

In my opinion, they are either on to something novel and interesting, or haven’t thought this through. Let’s hope for the sake of medicare’s pocketbook it’s the former.

Zafgen Raises $14 Million
-(Via BioSpace.com Featured News and Stories.)

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$85M is quite a haul but Pacira isn’t your normal, early stage delivery company. They already have an approved and marketable product in DepoFoam, a delivery technology that provides sustained-release delivery of injectable medications (e.g.; biologics).

Pacira has created formulations for six of the current top selling biologics; including EPO, G-CSF, hGH, INF-, FSH, and one undisclosed drug and intends to develop one or more of these assets as part of a biosimilar/bioimprovement strategy.

It seems this company is poised for a win. With the huge biosimilar push from insurers and a method for improved biologics dosing from companies, they have the market covered from both sides.

Pacira Pharmaceuticals, Inc. Raises $85 Million
-(Via BioSpace.com Featured News and Stories.)

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Under BBM’s proposal, BBM would acquire all of the outstanding shares of YMI common stock for consideration per share of $0.50 in cash plus 0.375 share of BBM common stock (aggregating for all YMI stockholders approximately 45% of the combined company’s outstanding stock after giving effect to the merger). The cash portion of BBM’s proposal represents a premium of 84.5% above the closing price of YMI common stock of $0.271 on November 12, 2008 (and a substantially greater premium taking into account the value of the BBM stock issued in the merger).

Alternatively, if YMI’s board of directors prefers not to negotiate a merger as proposed, BBM is willing to undertake a tender offer at a cash price of U.S. $0.60 per share for at least 90% of the shares of YMI Corporation.

BBM is a holding company that had formerly been operating in the telecommunications space but who can blame them for switching over to biotech.  There aren’t a ton of industries with literally hundreds of opportunities trading below their level of cash.

Additionally, it’s not like YM doesn’t have a growth driver, they are developing nimotuzumab, an epidermal growth factor receptor (EGFR)-targeting monoclonal antibody that it hopes will prove safer than marketed EGFR drugs such as Erbitux (cetuximab, ImClone). Their European partner (OncoScience) is already enrolling patients in a Phase III study in adult glioma patients, as well as in a Phase IIb/IIIa study in combination with gemcitabine in patients with advanced pancreatic cancer.

This is a tough call for YM; the BBM offer clearly undervalues the company but if their near term cash requirements exceed the ~$55M they have on hand, there might be little alternative.  We just saw Genelabs Technologies agree to a similar deal from GSK.  They were picked up for a little less than half cash on hand.

For big pharma/biotech… and er… holding companies, small companies are fish in a barrel.

BBM Announces Offer to Acquire YM BioSciences for US$29 Million; YM BioSciences Believes Offer to be too Low but will Present to Board
-(Via BioSpace.com Featured News and Stories.)

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Included within this group of non-core assets were:
- 4 of its 5 buildings for $6M ~($1.3M net cash to Neurogen)
- chemical library for $3M

I try and not use cliches if at all possible but I’ll make an exception for Neurogen; desperate times call for… well, you know the rest.

Neurogen Corporation Announces Agreements for Sale of Non-Core Assets for Combined $9 Million
-(Via Business Wire Health News.)

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• No Related Post

Can somebody explain to me how it is possible to launch a drug without having released results of a single phase 3 trial or have filed an NDA? Anybody?

Accera, Inc. Completes $35 Million Series C Financing
-(Via PR Newswire: Biotechnology.)

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ArQule and Daiichi Sankyo announced that they have entered into two agreements that form the basis of a strategic relationship for the development and discovery of novel oncology therapeutics. One agreement covers the license of ARQ 197 and the other is an R&D agreement.

ARQ 197 is a phase 2 stage, selective inhibitor of c-Met, a receptor tyrosine kinase. When abnormally activated, c-Met plays multiple roles in aspects of human cancer, including cancer cell growth, survival, angiogenesis, invasion and metastasis. Pre-clinical data have demonstrated that ARQ 197 inhibits c-Met activation in a range of human tumor cell lines, including clear cell sarcoma, and shows anti-tumor activity against several human tumor xenografts.

Insights into the binding of ARQ 197 to c-Met formed the basis of ArQule’s discovery platform, which the Company is leveraging to design a new type of kinase inhibitors. These compounds will be intended to selectively inhibit each targeted kinase potently, selectively and without competing with ATP (adenosine triphosphate, an energy source for cells). The Company is assessing the potential of multiple kinases as targets for this drug discovery platform, named AKIP™, and is applying the platform to discover and validate compounds that inhibit these kinase targets with mechanisms similar to that of ARQ 197.

ARQ 197 Agreement Summary
- Exclusive co-development and co-commercialization agreement
- Upfront: $60 million
- Daiichii has sole rights in Japan and other asian countries
- Cost sharing (with ArQule’s costs being covered within milestone payments)

Kinase Inhibitor Discovery Agreement Summary
- exclusive license and co-commercialization agreement for two kinase targets
- Daiichi funds portion of research
- Upfront: $15M
- ArQule retains co-commercialization option in US

This is the second largish, but not killer, deal completed by ArQule in oncology. The 2004 deal with Roche over ARQ 501 (E2F-1 program) is currently in phase 2 trials with further development subject to Roche picking up the option. The company was in pretty reasonable shape cash-wise, with $130M in the bank not counting the new $75M from Daiichi only strengthens their position.

ArQule, Inc. and Daiichi Sankyo Co Ltd. Enter Into Strategic R&D Partnership to Progress Novel Compounds to Target Cancer; Total Cash Upfront to is $75M
-(Via BioSpace.com Featured News and Stories.)

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TorreyPines stock is down ~97% on the year and they are running out of cash so I can’t imagine they got a great deal on this program (hence withholding the price), but when you’re fighting to stay alive, any cash that gets you to the next milestone is important.

TorreyPines Therapeutics, Inc. Sells Alzheimer’s Disease Genetics Program to Eisai Company, Ltd.
-(Via BioSpace.com Featured News and Stories.)

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The ChemoFx Drug Response Marker is a laboratory test that determines how an individual patient’s cancer cells will respond to different chemotherapy agents prior to initiating chemotherapy. Using ChemoFx to help select treatment can lead to better clinical outcomes while reducing exposure to toxic, ineffective chemotherapeutic agents. Clinical trials have demonstrated the potential for 1.4 times longer overall survival and a two- to three-fold improvement in progression-free cancer survival when ChemoFx is used in advance of making a therapeutic choice.

Interesting brute force method of testing for efficacy. I’m guessing the vast majority of this money goes into “product awareness.” It doesn’t matter how good your product and service is if no one knows about it.

Precision Therapeutics Secures $43 Million in Venture Capital Funding
-(Via PR Newswire: Pharmaceuticals/Biotechnology.)

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BTG has granted the worldwide commercialization and development rights of BGC 945, a novel anticancer compound, to Onyx in exchange for a potential $320M.

BGC 945 is a novel compound that inhibits thymidylate synthase (TS), an enzyme involved in cell growth and division. However, unlike traditional TS inhibitors, BGC 945 enters tumour cells via the alpha-folate receptor, which is over-expressed in certain tumour types, including ovarian, lung, endometrial and mesothelioma cells, but has a restricted expression profile in normal tissues.

Terms
—————-
Upfront: $13M
Milestones: $72M up to approval and $235M for approval and commercial successes in addition to royalties.
—————-

BTG has progressed BGC 945 into late-stage preclinical development in collaboration with The Institute of Cancer Research (ICR) where the compound was discovered. BTG will share approximately 10% of the upfront and milestone revenues it receives relating to BGC 945 with ICR plus a pass-through royalty.

BTG plc Signs Up To $320 Million Drug Deal With Onyx Pharmaceuticals, Inc.
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Pfizer Discontinues Development Program for Its Phase 3 Obesity Compound (CP-945,598)
-(Via Business Wire Health News.)

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Genzyme announced that they have entered a strategic alliance for the development and commercialization of Prochymal and Chondrogen, two novel, late-stage adult mesenchymal stem cell treatments that hold significant potential to treat a wide range of diseases. These stem-cell products are designed to provide therapeutic benefit by controlling inflammation, promoting tissue regeneration, and preventing scar formation.

Prochymal is currently being evaluated in two phase 3 trials for graft vs. host disease (GvHD) and one phase 3 trial for Crohn’s disease; data from all three trials are expected in 2009. It is also being studied in phase 2 trials for type 1 diabetes and chronic obstructive pulmonary disease. A phase 2 trial of Prochymal for acute myocardial infarction and a phase 2/3 trial of Chondrogen for osteoarthritis of the knee are expected to begin soon.

Prochymal has been granted Fast Track status by the FDA for GvHD and Crohn’s disease, and is the first stem cell product to receive FDA expanded access approval, making the product available now to children with life-threatening GvHD. It has also been granted Orphan Drug designation by the FDA and EMEA for GvHD. U.S. regulatory approval in this indication is anticipated as early as the end of next year; E.U. approval is expected in 2010.

Terms
———————

I think this is a pretty good (albeit pretty rich) deal all around. Genzyme gains a potentially first-in-class therapeutic modality highly touted as the potential, “future of medicine”, while Osiris gains a hefty chunk of cash and the Genzyme’s competence in marketing and delivering complex products. This fact can’t be overlooked; the best deal isn’t always the one with the highest upfront or larger royalty back end, rather, codevelopment / copromotion deals like this often require things that can’t be placed on a balance sheet in order to be successful: cooperation and expertise.

Starting with the signing of the Isis deal for mipomersen, it is clear to me that Genzyme understands these qualitative aspects of the alliance process and is offering more than just cash and this, in my opinion, has probably given them the edge (in the eyes of out-licensing biotechs) over companies with larger pocketbooks.

Osiris Therapeutics, Inc. Leaps on $1.38 Billion Genzyme Corporation Stem-Cell Deal
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Fidelity Biosciences has injected $65 million into EnVivo Pharmaceuticals Inc. and bought out all other venture investors in the neurological-drug developer.

EnVivo Pharmaceuticals was founded in 2001 and currently has 38 FTEs. EnVivo had raised ~$63.2M in three funding rounds, $14.9M Series A in October 2002 and $24.3M Series B in September 2004, $24M Series C in September 2006. Investors included scientific founders, Fidelity Bioscience Group, BBBC Investor Group that includes Baylor College of Medicine, and CoGene BioTech Ventures.

Fidelity Biosciences Injects $65M, Takes Over EnVivo Pharmaceuticals, Inc.
-(Via BioSpace.com Featured News and Stories.)

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Image via Wikipedia

Theratechnologies and EMD Serono, US arm of Merck KGaA, announced they have entered into a collaboration and licensing agreement for the exclusive commercialization rights to tesamorelin in the United States for the treatment of excess abdominal fat in HIV patients with lipodystrophy. Theratechnologies retains all tesamorelin commercialization rights outside of the US.

Tesamorelin is a growth hormone-releasing factor analogue with therapeutic potential in a variety of anabolic and lipolytic indications and is in the final stages of its second Phase 3 clinical trial to assess the safety and efficacy when used to reduce visceral adipose tissue in HIV patients with lipodystrophy. The purpose of the study is to confirm the results of the first Phase 3 study, concluded in October 2007.

Terms
——————–
Upfront: $30M
Equity Investment:$8M (3.6% ownership; $3.67/share)
Milestones: $185M

Theratechnologies will be responsible for conducting research and development for additional indications. EMD Serono will have the option to co-develop and commercialize additional indications for tesamorelin in the US. EMD Serono will equally share in the development costs related to such additional indications if it exercises its option. Theratechnologies will, in such case, also have the right, subject to EMD Serono’s agreement, to opt to co-promote such additional indications.

Theratechnologies Inc. and EMD Serono, Inc. Announce Collaboration and Licensing Agreement for Tesamorelin in the United States; to Receive up to $215 Million
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Image via Wikipedia

Alnara Pharmaceuticals announced today that it has secured $20 million in Series A venture capital financing. The round was co-led by Frazier Healthcare Ventures and Third Rock Ventures, and included co-investor Bessemer Venture Partners. Proceeds from the financing will be used to accelerate the development of non-systemic protein therapeutics.

The newly formed company is being led by Alexey Margolin, Ph.D., chief executive officer, and an experienced Board of Directors. Dr. Margolin is the former chief scientific officer of Altus Pharmaceuticals Inc. Alnara’s Board of Directors is chaired by Richard Aldrich, co-founder of Vertex and Sirtris, and includes Christoph Westphal, M.D., Ph.D., chief executive officer of Sirtris, a GSK Company; James Topper, M.D., Ph.D., general partner, Frazier Healthcare Ventures; and, Robert Tepper, M.D., partner, Third Rock Ventures.

The press release went on to say… bla bla bla… new approach…. bla bla bla… we’re going to succeed faster than everyone else because we’re unique and special. I’m paraphrasing… but, in all seriousness, good luck with that.

Alnara Pharmaceuticals, Inc. Secures $20 Million in Series A Round
-(Via Business Wire Health News.)

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