Lycera announced the closing of a $36M Series A round of funding. The company is developing novel small-molecule pharmaceuticals to treat autoimmune diseases such as rheumatoid arthritis and inflammatory bowel disease, has received $10 million as a first tranche of the financing and will receive the remainder of the proceeds in two tranches as specific milestones are met. InterWest Partners, ARCH Venture Partners and Clarus Ventures co-led the financing. EDF Ventures, which led a seed financing in November 2006, is also participating.

They are focused on the discovery and development of small-molecule immunomodulators for the treatment of immunologic diseases, including psoriasis, rheumatoid arthritis, lupus erythematosis, inflammatory bowel disease and transplant rejection. Originally founded by Dr. Gary Glick as a spin-out of the University of Michigan, Lycera is developing drug candidates that target two novel therapeutic pathways and have the potential for first-in-class oral efficacy without the adverse effects of current standard-of-care antiproliferative and immunosuppressive agents. Visit www.lycera.com for more information.

Lycera also announced that it has expanded its development initiatives for small-molecule immunomodulators through the addition of a program targeting the Th17 pathway discovered by Dan Littman, M.D., Ph.D. Dr. Littman, the Helen L. and Martin S. Kimmel.

Clarus’s Dr. Leiden added, “Lycera combines two of the most exciting, new small-molecule approaches for treating autoimmune diseases. The company will leverage the complementary expertise and discoveries of Dr. Glick in medicinal chemistry with those of Dr. Littman in immunology and the Th17 pathway. The Series A financing will enable Lycera to advance its first drug candidate through Phase II proof-of-concept studies and a second candidate into Phase I clinical trials.”

Lycera Closes $36 Million Series A

(Via Biospace)

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Synageva BioPharma announced the first closing of a financing raising $30 million. The round was led by Baker Brothers Investments. Other investors participating in the financing include Tullis Dickerson and Four Partners. As part of the transaction, Synageva announced that Robyn Samuels, Vice President with Tisch Family Interests, has joined its Board of Directors representing Four Partners. Subsequent closings of additional new and existing investors representing both large private equity and venture capital funds will occur over the next few weeks. These investments will be in addition to the $30 million already raised.

Synageva is a biopharmaceutical company dedicated to developing and commercializing novel, next generation, and follow-on protein therapeutics that leverage the unique competitive advantages of thier proprietary Synageva Expression Platform (SEP™). Synageva’s development programs address specific unmet medical or market needs in several therapeutic areas, including oncology, organ dysfunction, autoimmune diseases and rare disorders. They have generated a diverse pipeline of product candidates, including high-potency monoclonal antibodies with potentially up to 100-fold increased killing activity for cancer targets, novel proteins for rare diseases, and next generation and follow-on cytokines.

This funding will be utilized to advance Synageva’s products to later stages of development in order to maximize their value for partnership discussions. Specifically, we will be advancing three of our most promising development programs through IND, including two novel/ next generation monoclonal antibodies, and a novel protein therapeutic. Synageva is also pursuing partnerships for the development and commercialization of our later stage pipeline, in addition to collaborations with potential partner companies for producing other product candidates with favorable safety and efficacy profiles.

(via PE Hub)

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In retrospect… not a good idea.

Already up 189% today presumably after the short squeeze.

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I promise… they posting will return next week. Due to the recent layoff at my company, I’m going to have plenty of time to make up for the last few weeks.

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AVEO and Biogen announced a strategic collaboration for the development and commercialization of AVEO’s novel discovery-stage ErbB3-targeted antibodies for the potential treatment of cancer and other diseases.

TERMS
————————-
- AVEO will receive upfront and milestones
- Biogen will have exercisable option at proof of concept for dev and commercialization rights outside North America
- AVEO retains all US commercialization rights
————————-

ErbB3 is a type 1 tyrosine kinase receptor of the EFGR family that is widely expressed in human carcinomas, with demonstrated overexpression – correlated with poor prognosis – in several different tumor types, including breast, ovarian, prostate, colorectal, pancreatic, gastric and head & neck cancers. In vivo studies conducted by AVEO demonstrated that elevated ErbB3 levels can potently drive breast tumor growth and may provide an escape mechanism to Herceptin® treatment. ErbB3 is also implicated in the development of resistance to EGFR tyrosine kinase inhibitors in non small cell lung cancer. AVEO has focused its ErbB3 antibody discovery efforts on identifying high affinity, high specificity antibodies that recognize ErbB3 on the cell surface and inhibit its activity. The market attractiveness of AVEO’s ErbB3 portfolio is bolstered by the success of other EFGR family inhibitors such as erlotinib, gefitinib and transtuzumab, which have unique patterns of resistance that may be addressed by an effective ErbB3 antibody.

AVEO Pharmaceuticals, Inc. and Biogen Idec, Inc. (Massachusetts) Form Strategic Alliance for Development and Commercialization of ErbB3-Targeted Antibodies

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All this talk by Astellas about taking over the board of directors and taking the decisision to the shareholders seems it may have been in vain. Gilead has agreed to acquire CV Therapeutics for $1.4B or $20/share through a tender offer and second step merger. - a $400M bump to the last Astellas offer of $16/share.

Terms
————————

1. The closing of the tender offer is subject to various conditions, including the tender of at least a majority of the outstanding shares of CV Therapeutics common stock in the tender offer and the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.
2. The transaction is not conditional on financing. Gilead intends to finance the transaction through available cash on hand.
3. The tender offer is expected to close during the second quarter of 2009.
4. Following completion of the tender offer, Gilead will acquire all remaining shares of CV Therapeutics through a second step merger at a price of $20.00 per share.

Gilead Sciences Agrees to Acquire CV Therapeutics for $20.00 Per Share

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There’s an article this morning on Bloomberg insinuating that the Pfizer/Wyeth, Genentech/Roche and now Merck/Schering-Plough mergers have placed pressure on the remaining members of big pharma to get into the game.  I implore them not too; megamergers are rarely, if ever, good for business.  Recent history suggests acquiring small companies with one major, late-stage pipeline drug is the way to go.  I’d argue that Lilly and Takeda with their slightly overpriced purchases of ImClone and Millennium respectively will come out much further ahead in the long run than Pfizer and Merck.

Hypothetically, let’s say major Pharma X has $10B in cash and is looking for strategic alternatives in this high cost of capital environment.  There are (simplistically) three options:

The most pressing issue facing Pharma X is the loss of revenue due to patent expiration and lack of a late-stage pipeline to replace the revenue. Addressing these issues should be the #1 priority in evaluating strategic alternatives. Period. I don’t care about cost-savings or share price or margin. In the long run, those things just don’t matter. Unless Pharma X is aching to collapse under its own bloat, they have to become more productive. Unfortunately for them, R&D productivity doesn’t scale with revenue or employee number. Larger companies simply just not as productive as smaller ones at bringing drugs to market and this fact alone should rule out a mega-merger.

So what are the strategic alternatives? I Looked at small-cap companies with a market cap greater than $250 million, and assuming a 30 percent premium to current market values, instead of blowing $10 billion on bankers and lawyer fees (and paying a ridiculous cost of capital to take out massive debt in a credit crunch), Pharma X could potentially acquire a staggering 22 companies with mid to late stage products and the platform technology to boot.

I realize this is a simple hypothetical and evaluating each alternative is vastly more complicated… but it does make you think; how is taking out billions of dollars of debt in order to not solve the major R&D productivity issue even an option? I could be just as brainless and suggest a preferred alternative; simply just admit you can’t beat the patent cliff, take a deep breath, and sell off key assets followed by the return of a substantial cash reserves to the shareholders.

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Not to be outdone by Pfizer / Wyeth, Merck and Schering-Plough announced that their Boards of Directors have unanimously approved a merger. Schering has a strong pipeline and was my best of breed to be acquired in the medium sized pharmaceutical space. I think Merck just made a nice step forward in solidifying itself as a top 5 pharmaceutical company in the near future.

Under the terms of the agreement, Schering-Plough shareholders will receive 0.5767 shares and $10.50 in cash for each share of Schering-Plough. Each Merck share will automatically become a share of the combined company. Merck Chairman, President and Chief Executive Officer Richard T. Clark will lead the combined company.

Based on the closing price of Merck stock on March 6, 2009, the consideration to be received by Schering-Plough shareholders is valued at $23.61 per share, or $41.1 billion in the aggregate. This price represents a premium to Schering-Plough shareholders of approximately 34 percent based on the closing price of Schering-Plough stock on March 6, 2009. The consideration also represents a premium of approximately 44 percent based on the average closing price of the two stocks over the last 30 trading days.

Upon closing of the transaction, Merck shareholders are expected to own approximately 68 percent of the combined company, and Schering-Plough shareholders are expected to own approximately 32 percent.

Financing
—————————————
- 44% cash and 56% stock.
- The cash portion will be financed with a combination of $9.8 billion from existing cash balances and $8.5 billion from committed financing to be provided by J.P. Morgan.

Transaction Structure
—————————————
- The transaction will be structured as a “reverse merger” in which Schering-Plough, renamed Merck, will continue as the surviving public corporation.
- The exchange ratio was calculated based on an agreed price of $26.25, with $10.50 in cash and $15.75 in Merck stock, based on a trailing thirty day volume weighted average price of $27.3109.
- Effective upon the merger, each Merck share will automatically become a share of the combined company.

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From hddod onFlickr

Sounds ominous, no?

Symphogen and Origen announced a collaboration to develop a transgenic chicken capable of producing human antibodies against a wide variety of disease targets. Origen will use its avian transgenic technology to develop transgenic chickens, which can be immunized with any disease target of interest, including diseases such as cancer and autoimmunity. Symphogen will apply its antibody discovery and expression platforms to create novel, recombinant fully human monoclonal and polyclonal antibody therapeutics against such targets. Both companies plan to employ the jointly developed transgenic technology to produce novel antibody therapeutics.

Under the terms of the agreement, both companies will provide funding for the development of transgenic, human antibody-expressing chickens using Origen’s avian transgenic technology. Origen will receive upfront license payments and further payments upon reaching defined research and development goals. In addition, Symphogen and Origen will pay each other royalties on products arising from the technology. Once human antibody-producing chickens are developed (in which will no doubt be a wonderful day for humankind), both companies will hold rights to develop products from those birds. Furthermore, Symphogen will have the right to purchase exclusive access to the collaboration technology for use to generate human recombinant antibody products. The two companies plan to address targets in the areas of infectious disease, cancer and autoimmune diseases.

Symphogen and Origen Collaborate to Produce Transgenic Chicken for Generation of Fully Human Antibody Therapeutics
(Via MarketWatch)

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Proteon Therapeutics announced it has successfully completed a $38 million Series B equity financing, started a Phase 1/2 clinical trial with its lead product, PRT-201, and has entered into an option agreement with Novartis for purchase of the company upon completion of a successful phase 2 trial.

Series B Details:
The Series B financing includes new investors, the MPM Bio IV NVS Strategic Fund L.P. and the Vectis Healthcare & Life Sciences Fund, along with existing investors TVM Capital, Skyline Ventures, Prism VentureWorks, Intersouth Partners and several of Proteon’s original angel investors. Concurrent with the investment, Proteon also announced the addition of Dr. Steven St. Peter, Managing Director of MPM Capital, to the Proteon Therapeutics Board of Directors.

Novartis Option Agreement Details:
Proteon further bolstered its cash reserves by entering into an agreement with Novartis whereby Novartis has been granted an exclusive option to acquire Proteon following the successful completion of a Phase 2 clinical study of PRT-201 with a potential secondary right to a global license under pre-agreed conditions. Including the initial acquisition payment plus potential additional regulatory milestone payments, the deal with Novartis could exceed $550 million.

PRT-201 Details: The compound is a recombinant human elastase that is being studied for its ability to improve arteriovenous fistula (AVF) surgery outcomes in patients requiring chronic hemodialysis. PRT-201 has been shown to cause dilation of segments of arteries and veins following topical intraoperative application in animals. Vessel dilation and increased blood flow through the fistula may decrease AVF maturation failure rates. Improved maturation rates may lead to fewer corrective surgical procedures, hospitalizations, lower costs, and less suffering for dialysis patients. PRT-201 also will be studied for its ability to prolong the patency of arteriovenous grafts (AVGs).

Proteon Therapeutics Completes $38M Equity Financing; Initiates Phase 1/2 Clinical Study of PRT-201 in Hemodialysis Patients and Signs Option Agreement With Major Pharmaceutical Company
(Via PR Newswire: Biotechnology.)

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Vertex, which is developing the hepatitis C virus (HCV) protease inhibitor telaprevir, will add two polymerase inhibitors to its HCV drug development portfolio through an agreement to acquire privately-held ViroChem Pharma in a stock and cash transaction. The move expands Vertex’s global presence in HCV and has the potential to enhance the profile and lifecycle of our telaprevir-based combination regimens.

Terms
—————————
- ViroChem shareholders will receive $100 million in cash and 9.9 million shares of Vertex common stock

- Actual number of shares of Vertex stock to be issued will be based on an average share price prior to the closing (will not exceed 11.0 million shares)

—————————

Following completion of the transaction, Vertex will own worldwide rights to ViroChem’s HCV drug development portfolio, including VCH-222 and VCH-759, which have demonstrated substantial reductions in plasma HCV RNA when dosed as single agents and have been well-tolerated in clinical studies to date. In particular, VCH-222 dosed as 750 mg twice daily resulted in a median 3.7 log10 decrease in HCV RNA at the end of dosing in a three-day viral kinetic study, representing the most substantial reduction in viral load reported to date with an investigational HCV polymerase inhibitor dosed as a single agent. Vertex expects to begin clinical evaluation of novel combination regimens of its HCV protease inhibitor telaprevir, currently in Phase 3 clinical development, in the second half of 2009.

Two ViroChem HCV polymerase inhibitors, VCH-222 and VCH-759, are currently in clinical development. ViroChem also has a preclinical program directed at the discovery of novel HCV NS5a inhibitors. The status and profile of each clinical compound is detailed below.

VCH-222: VCH-222 is an oral non-nucleoside inhibitor of the HCV NS5B polymerase that recently completed a viral kinetic study in HCV patients. In this study involving five treatment-naïve genotype 1a and 1b HCV infected patients, VCH-222 dosed as 750 mg twice daily resulted in a median 3.7 log10 decrease in HCV RNA – equivalent to a 5,000-fold reduction in virus in the blood – at the end of three days of dosing. The results were consistent from patient to patient, and across HCV genotype 1 subtypes, and represent the most substantial reduction in viral load reported to date with an investigational HCV polymerase inhibitor dosed as a single agent. In clinical evaluations to date, VCH-222 has been well-tolerated, with no serious adverse events observed. VCH-222 has completed 28-day non-clinical toxicology studies in two species.

VCH-759: VCH-759 is an oral non-nucleoside inhibitor of the HCV NS5B polymerase that has completed Phase 1b clinical development. In a Phase 1b trial reported at a medical conference in 2007, VCH-759 dosed as 800 mg three times daily showed a mean maximal 2.5 log10 reduction in HCV RNA and a median 1.7 log10 reduction in HCV RNA at the end of 10 days. VCH-759 was also well-tolerated with no serious adverse events observed in clinical studies to date. VCH-759 has completed 28-day non-clinical toxicology studies.

Future clinical plans: Vertex plans to conduct additional dose-ranging studies of VCH-222 as a single agent and in combination with pegylated interferon and ribavirin. Vertex plans to initiate a first clinical study combining telaprevir with a ViroChem HCV polymerase inhibitor in the second half of 2009. Data from in vitro HCV replicon studies suggest that VCH-222 and VCH-759 may provide synergistic or additive antiviral activity to the HCV protease inhibitor telaprevir, thus creating the potential for a non-cross resistant, complementary profile in exploratory clinical studies.

Vertex Pharmaceuticals Strengthens HCV Drug Development Portfolio, Adds Novel Polymerase Inhibitors to Shape New Combinations with Telaprevir
(Via Business Wire Health News.)

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Astellas announced that its indirect subsidiary, Sturgeon Acquisition, Inc., has commenced a cash tender offer for all outstanding shares of common stock of CV Therapeutics at a price of US$16.00 per share. The offer and withdrawal rights are scheduled to expire at 12:01 a.m., New York City time on March 27, 2009, unless the offer is extended. The Company also announced that it is considering taking action in connection with CV Therapeutics’ 2009 Annual Meeting.

The Astellas tender offer represents a 41% premium to CV Therapeutics’ closing share price on January 26, 2009, the day prior to the public disclosure of Astellas’ proposal, and a 69% premium to CV Therapeutics’ 60-day average closing price ending January 26th. The tender offer is not conditioned on financing and represents a total equity value of approximately $1.1 billion.

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Heptares Therapeutics, the drug discovery company focused on drugs targeting G-protein-coupled receptors (GPCRs), annnouced it has raised $30M (GBP21M) of equity finance in a successful Series A private round from three blue-chip international venture capital firms. Clarus Ventures led the syndicate, which includes the founding investor, MVM Life Science Partners, and the Novartis Option Fund. All three investors contributed equally. Michael Steinmetz for Clarus Ventures and Anja Koenig for the Novartis Option Fund have joined the Heptares Board of Directors as non-executive directors.

Over the next three years, Heptares intends to use the new funds to develop its own pipeline of small-molecule drug candidates using its proprietary StaR(TM) technology platform. These novel drug candidates will be developed against currently intractable GPCRs that are highly validated targets for the treatment of disease. Further progress in the application of StaR technology over this period is also expected to yield commercial partnering opportunities outside Heptares’ core focus, for example, improved therapeutic antibodies against GPCRs.

Heptares’ StaR (Stabilised Receptor) technology platform enables the Company to overcome this technology hurdle by engineering and purifying GPCRs in stable and functional conformations that retain their drug-binding characteristics. The Company can then apply contemporary drug discovery approaches, such as crystallisation and structure-based design, biophysical analysis of ligand interactions, and fragment screening to stabilised GPCRs. This unique approach is expected to radically improve the chances of finding drugs to previously intractable targets and enable the development of safer and more selective therapeutic agents.

Heptares was founded in 2007 as a spin-out from the MRC Laboratory of Molecular Biology (Cambridge, UK) based on world-class pioneering research and expertise in GPCRs. In 2008, the StaR technology was used successfully to elucidate the three-dimensional atomic resolution structure of the beta-1 adrenergic receptor, which is the site of action of beta blockers.

Heptares Secures GBP21 Million in Series A Fund Raising to Accelerate Development of Pipeline of Small Molecules Against High-Value GPCR Drug Targets
(Via PR Newswire: Biotechnology.)

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Just a week after NeuroSearch failed a phase II pain trial (ABT-894), they’ve inked a collaboration which will focus on new CNS therapeutics based upon defined ion channel targets
NeuroSearch is eligible to receive equity payments and research funding of up to USD 30 million over the three years of the alliance.

Terms
————————–
Upfront: $5M
Potential Research Funds: $8M
Equity: $17M
Milestones: Up to $320M if all drugs reach the clinic
————————–

NeuroSearch will be responsible for the drug discovery programmes under the collaboration and potentially early development of novel drug candidates. Lilly will have various options to exercise license rights to individual compounds covered by the agreement and related intellectual property. Upon exercise of license rights, Lilly will be responsible for all subsequent development and commercialisation activities. For each product, successfully developed and commercialized under the alliance, NeuroSearch may be entitled to milestone payments of up to USD 320 million (DKK 1,868.2 million) plus royalties on the product’s global sales.

NeuroSearch, Lilly ink multimillion-dollar CNS deal
(Via Fierce Biotech.)

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Orexo has signed an exclusive development agreement with “a large healthcare company”, providing for joint development within Orexo’s OX17 program for gastroesophageal reflux disease (GERD), and will be discontinuing all other licensing discussions for Ox17.

During this development work, Orexo will continue negotiations to enter into an appropriate global exclusive license agreement including the whole of Orexo’s Ox17 program and related intellectual property. This license agreement is anticipated during 2009. The financial terms were not disclosed.

Torbjörn Bjerke, President and CEO of Orexo “I am delighted to announce this new development agreement, although we are unable to disclose many details at this time. We expect to be able to create a first choice therapy for GERD with this partner, and will make further announcements at the appropriate time”.

My top two guesses are AstraZeneca and Takeda… got other ideas; leave them in the comments.

(Via Business Wire)

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