Patent Docs

Allergan Announces Favorable CAFC Decision

    By Donald Zuhn --

On Thursday, Allergan, Inc. announced that the U.S. Court of Appeals for the Federal Circuit has affirmed judgment in favor of Allergan and Roche Palo Alto, LLC in a patent infringement suit against Apotex, Inc., Apotex Corp., and Novex Pharma ("Apotex").  As a result of this decision, Apotex will not be able to obtain FDA approval to market a generic version of Allergan's ACULAR® (ketorolac tromethamine ophthalmic solution) product.  ACULAR® is approved for use in treating ocular itching due to seasonal allergic conjunctivitis and post-operative inflammation in patients following cataract surgery.

Last year, Apotex appealed a District Court ruling that its proposed generic product infringed Roche Palo Alto's U.S. Patent No. 5,110,493 (which Roche licenses to Allergan), and that the '493 patent was a valid and enforceable.  The District Court also determined that the effective date of approval of Apotex' Abbreviated New Drug Application (ANDA) would have to wait until after the '493 patent expired on May 5, 2009.

Abbott Agrees to Offer AIDS Drug at Reduced Price

    By Donald Zuhn --

On Tuesday, Abbott announced that it had reached an agreement with World Health Organization (WHO) Director General Margaret Chan to reduce the price of its Kaletra/Aluvia (lopinavir/ritonavir) AIDS drugs in the developing world.  In particular, Abbott will be offering the drugs to about forty low and low-middle income countries (as defined using World Bank criteria) at a price of $1,000 per patient per year - or about 55% less than the average current price at which Abbott sells the drugs in these countries (and less than the price of any generic version of the drugs).

According to Abbott's statement, the price reduction will serve to "further increase access and address the debate around pricing of HIV medicines . . . while preserving the system that enables the discovery of new medicines."  Abbott added that "[t]he patents of scientists and inventors must exist so that there are incentives for sustained research and development," without which "the miracle drugs the world enjoys today, including HIV medicines, would not exist."

Abbott's decision to reduce the price of its AIDS drugs in the developing world constitutes a reversal of its earlier decision to withdraw its products from Thailand in response to that country's issuance of compulsory licenses for Kaletra (see "No New Abbott Medicines for Thailand"), which in turn resulted from Abbott's failure to reach an agreement with the Thailand government on a reduced price for Kaletra.  With respect to its dispute with Thailand, Abbott stated that it "appreciates and fully respects the suggestion of Director General Chan that more work needs to be done with the government of Thailand to achieve a positive outcome, " but noted that "Kaletra capsules remain available in Thailand and will be eligible for the new price."

A Reuters report indicates that despite Abbott's announcement, the company's dispute with Thailand continues, and as a result, Abbott will not be offering Aluvia (a newer form of Kaletra) in Thailand.  According to the Reuters report, AIDS activists have widely criticized this decision since Aluvia is a heat-stable form of Kaletra that eliminates the need for costly cold storage in resource-poor countries.

For additional information concerning the issue of compulsory licensing in Thailand, please see:

• "No New Abbott Medicines for Thailand," March 14, 2007
• "More Compulsory Licensing in Thailand," February 1, 2007
• "Thailand Compulsory License Still in the News," December 18, 2006
• "Thailand Issues Compulsory License for AIDS Drug," December 6, 2006

They Just Don't Get It - "Patent Reform" at the USPTO

    By Kevin E. Noonan --

As has been reported elsewhere (see Patently O: "Rumors Continuations & Claims"), the U.S. Patent and Trademark Office appears to be ready to issue "final rules" on changing continuation application practice, said PTO's Commissioner of Patents John Doll today at a meeting of the District of Columbia Bar Association.

According to Commissioner Doll, the Patent Office has delivered the "final rules" to the Congressional Office of Management and Budget (OMB), which will take a minimum of 90 days to review the proposed rule changes.  Thereafter, the rules will be published in the Federal Register.

The extent of the good news associated with this announcement is the concession by Commissioner Doll that the unprecedentedly large (and unprecedently negative) public commentary submitted in response to the rules as initially proposed has had an effect.  Commissioner Doll hinted that the final rules have been modified, explicitly in response to some of the comments.  Among the modifications alluded to in his comments were changes in the proposed "representative claim" proposal as well as increased limits on the numbers of independent and total claims.  Also purportedly changed is the rule that all divisional applications be filed at the same time to retain the initial priority date, and the limits on the number of continuing applications that will be permitted.

Readers of this space will recall some of the more draconian portions of the proposed rules (see below).  These include limiting continuations to one per application, and depriving applicants subject to claim restriction (based on claiming more than one invention in a single application) of the right to pursue the restricted claims after the original application grants.  The number of claims the Office was willing to examine was limited to ten "representative" claims chosen by the applicant, including all independent claims.  Claims restricted from an application by Patent Office determination that they were independently-patentable inventions would be required to be filed during the pendency of the restricted application in order to retain the priority right.  And the Office proposed requiring applicants to identify and characterize prior art with particularity regarding individual claim limitations, without any concomitant changes in Rule 56 to shield patent counsel from later accusations of inequitable conduct.

Commissioner Doll is scheduled to address the American Bar Association's Intellectual Property Section meeting in Washington over the next three days (April 12-14, Arlington VA).  It will be interesting to see whether Commissioner Doll is more forthcoming in his remarks during this meeting.  Continued strict secrecy is likely to be a harbinger that the "modified" rules are not much better than the original rules deemed by many to be extremely unsatisfactory.  If so, litigation over the competency of the Patent Office to make such sweeping incursions on applicants' statutory rights is possible.

For additional information regarding this topic, see:

• "Patent Applicants Beware: The Rules Are Changing (Again) - Part 1," Patent Docs, November 6, 2006

• "Patent Applicants Beware: The Rules Are Changing (Again) - Part 2," Patent Docs, November 6, 2006

• "USPTO Continuation Practice Rules," Patently O, April 11, 2007

GTC Biotherapeutics Licenses Nuclear Transfer Patents from stART Licensing

    By Donald Zuhn --

On Tuesday, GTC Biotherapeutics, Inc. announced that it had been granted a non-exclusive worldwide license from stART Licensing, Inc. to use stART's nuclear transfer patents and patent applications to produce therapeutic proteins in the milk of transgenic animals.

GTC Biotherapeutics, Inc. commercializes therapeutic proteins through transgenic animal technology.  GTC's ATryn®, a recombinant form of human antithrombin, was the first transgenically produced protein to be approved anywhere in the world (the European Commission has approved ATryn® for the treatment of deep vein thrombosis).  ATryn® is produced in the milk of transgenic goats that have been developed by micro-injection.

stART Licensing, Inc. is a joint venture between Geron Corp. and Exeter Life Sciences, Inc.  stART manages and licenses a portfolio of patent rights related to animal reproductive technologies, including the patents and patent applications involved in the licensing agreement.  The licensed nuclear transfer technology was originally developed by the Roslin Institute for the cloning of Dolly the sheep.

Financial terms of the agreement include a $200,000 payment to stART and a split of 278,370 shares of GTC's common stock between stART and Exeter.  In addition, GTC will pay royalties to stART on any products that GTC develops with the licensed technology.  The agreement will remain in force through the expiration of the last of stART's nuclear transfer patents, which GTC expects to expire in 2016.  While the patents and patent applications involved in the agreement have not yet been disclosed, the licensed technology may include U.S. Patent Nos. 6,525,243; 6,252,133; and 6,147,276; and a number of U.S. patent applications.

According to GTC's statement, the licensed technology will be utilized, as an alternative to micro-injection, to develop transgenic animals that incorporate a transgene into their genome for the expression of therapeutic proteins in the transgenic animal's milk.  GTC also noted that by using nuclear transfer technology, it will be able to speed up the development of large-scale transgenic production capacity.

GTC Chairman and CEO Dr. Geoffrey Cox stated that GTC's "intellectual property portfolio provides patent protection for both the practice of our technology and the commercialization of our products," noting that GTC had received a U.S. patent in 2006 "for the production of therapeutic proteins in the milk of any transgenic mammal."  According to Dr. Cox, the licensed stART technology would help "support[] our strategic focus on the development and commercialization of recombinant plasma proteins and monoclonal antibodies."

Dow Denies That It Is Buyout Target

    By Donald Zuhn --

On the heels of last weekend's report that a consortium of Middle Eastern investors and American buyout firms was preparing to pull off the world's biggest leveraged buyout - a $50 billion buyout of Dow Chemical Co., Dow countered today that it has had no discussions concerning a leveraged buyout.

The report of the leveraged buyout first appeared in The Sunday Express, a London tabloid known more for its coverage of conspiracy theories regarding the death of Princess Diana than for its business reporting.  According to the Express, investors from Saudi Arabia, Kuwait, Bahrain, Qatar, United Arab Emirates, and Oman, in conjunction with a number of U.S. buyout firms includingKohlberg Kravis Roberts had assembled a financing package for a break-up bid of between $52 and $58 per share.

On Monday, Dow denied the Express buyout report, with Dow spokesman Chris Huntley stating that "a friendly takeover [of Dow] is not going to happen," and that a hostile takeover was unlikely given Dow's size.

Patent Profile: Oncolytics Announces Issuance of Reovirus Production Patent

    By Donald Zuhn --

Last month, Oncolytics Biotech Inc. announced that it had been granted U.S. Patent No. 7,186,542.  The '542 patent, which relates to methods of producing reovirus from a cultured cells, was the nineteenth U.S. patent to be awarded to the Calgary-based biotech company.  As we reported last week, Oncolytics was recently awarded its twentieth patent, which is directed to methods of sensitizing neoplastic cells to irradiation by using reoviruses.

According to the statement released by Oncolytics, the '542 patent "expands on similar manufacturing patents secured by the Company."  Oncolytics currently has an ongoing clinical program related to the use of REOLYSIN®, Oncolytics' proprietary formulation of the human reovirus, alone or in combination with radiation or chemotherapy, for the treatment of a number of human cancers, including colorectal, prostate, pancreatic, non-small cell lung, melanoma, and ovarian cancer.

Reovirus (Respiratory Enteric Orphan virus) is found naturally in sewage and water supplies and inhabits human respiratory and bowel systems.  Because tumor cells bearing an activated Ras pathway lack dsRNA-activated protein kinase (PKR - protein kinase dsRNA), they are unable to activate a PKR-mediated anti-viral response.  As a result, such cells are susceptible to reovirus infection and subsequent cell death.  Normal cells, however, do not possess activating mutations of Ras, and thus, are able to terminate reovirus infection through normal PKR activity.

The '542 patent issued from U.S. Application No. 10/916,378 and claims the benefit of U.S. Application No. 10/097,183, filed March 14, 2002, and U.S. Provisional Application No. 60/276,734, filed March 16, 2001.  Representative independent claims 1 and 2 of the '783 patent recite:

1.  A method of producing reovirus from a culture of cells, comprising the steps of:
    (a)  providing a culture of human embryo kidney (HEK) cells which has been infected by the reovirus;
    (b)  extracting the reovirus from the cells by adding a detergent to the culture of HEK cells and incubating for a period of time; and
    (c)  collecting the reovirus.

2.  A method of producing infectious reovirus, comprising:
    (a)  providing a culture of human embryo kidney (HEK) 293 cells which has been infected by reovirus;
    (b)  extracting the virus from the cells by adding octoxynol-9 to 10 to the culture and incubating at about 25ºC. to about 37ºC. for about 10 minutes; and
    (c)  collecting the reovirus.

From Toy Poodle to Rottweiler: Why Is Fido So Small (or Large)?

    By Kevin E. Noonan ---

Single nucleotide polymorphisms (SNPs) have been detected since the beginning of the third revolution in genetics characterized by cloning, sequencing, and the various organismal genome projects (rediscovery of Mendel's laws being the first and Watson and Crick's elucidation of the structure of DNA being the second).  SNPs were first associated with restriction length fragment polymorphisms, a technique developed for chromosomal gene mapping (particularly for disease genes) and disease trait genealogy in the days before the entire human genome had been sequenced.  One well-known use of the technique was Mary Clare King's identification of Central American death squad victims from their remains found in mass graves, and the existence of SNPs has been predicted to be the key to the new world of personalized medicine.

One of the more interesting SNPs, and one having global consequences, was reported in Science last week.  Nathan Sutter and his colleagues at the National Human Genome Research Institute (a part of the National Institutes of Health) and several other university and corporate research centers reported that a SNP in the insulin-like growth factor 1 gene (IGF-1) in dogs is responsible for the vast differences in size between different breeds.  Using both traditional genetic tools and the products of the dog genome project, these workers found an SNP shared by all "miniature" dog breeds and absent from all larger breeds.  The group's work was facilitated by the great range in size between breeds (the largest among terrestrial vertebrates), the well-established delineation of breeds and maintenance of breed standards by international dog breeding societies, and the completion of the dog genome project.  The genetic results were supported by biochemical studies showing lower IGF-1 levels in blood serum from small dogs than large dogs.

Since all domestic dogs are descendants of the common grey wolf found throughout Eurasia, the existence of this trait is the consequence of at least 15,000 years of human selective breeding (although the great majority of dog breeds have been developed over the past few hundred years).  It is readily apparent why this trait was selected for during domestication, producing breeds that are smaller than the wolf, and thus less of a threat to man, as well as improving characteristics of domesticated breeds such as reduced food (and water) requirements.  The persistence of the mutation in the almost 15,000 years between initial domestication and active human selection for miniature dog breeds suggests that the variant gene containing the SNP is important for inter alia maintaining the tendency for dog breeds smaller than the size of the original grey wolf stock.

Interestingly, until the publication of these results, there was no consensus on the genetic causes of the great diversity in breed size, with researchers positing such variables as increased mutation or recombination rates, distribution of short repeat sequences in the dog genome, differences in regulatory genes, and readily-altered developmental programming.

The implications for human development are unclear, but suggest that human size variation may also be influenced by such polymorphisms.  Dissection of SNP variant frequency in humans or other mammalian species at IGF-1 can be expected in view of the Sutter team's results.

Sutter et al., 2007, Science 316(5821): 112-115 (April 6, 2007)

Court Report

    By Sherri Oslick ---

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.

Bayer Healthcare AG et. al. v. Teva Pharmaceuticals U.S.A., Inc.
1:07-cv-00195; filed April 5, 2007 in the District Court of Delaware

Infringement of U.S. Patent Nos. 4,990,517 ("7-(1-pyrrolidinyl)-3-Quinolone- and -Naphthyridonecarboxylic Acid Derivatives as Antibacterial Agents and Feed Additives," issued February 5, 1991) and 5,607,942 (same title, issued March 4, 1997) following a paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Bayer's Avelox® (moxifloxacin hydrochloride, an antibiotic used to treat infection).  View the complaint here.

Sanofi-Aventis et. al. v. Barr Laboratories Inc.
2:07-cv-01605; filed April 5, 2007 in the District Court of New Jersey

Infringement of U.S. Patent No. 6,514,531 ("Controlled-release Dosage Forms Comprising Zolpidem or a Salt Thereof," issued February 4, 2003) following Barr's filing of an ANDA to manufacture a generic version of Sanofi-Aventis' Ambien CR® (controlled release zolpidem tartrate, used to treat insomnia).  View the complaint here.

Merial Ltd. et. al. v. Intervet, Inc.
1:07-cv-00630; filed April 4, 2007 in the District Court of the District of Columbia

Infringement of U.S. Patent No. 7,192,594 ("Postweaning Multisystemic Wasting Syndrome and Porcine Circovirus from Pigs," issued March 20, 2007) based on Intervet's manufacture and sale of its Porcine Circovirus Vaccine Type 2.  View the complaint here.

Otsuka Pharmaceutical Co., Ltd. v. Sun Pharmaceutical Industries Ltd.
3:07-cv-01516; filed March 30, 2007 in the District Court of New Jersey

Infringement of U.S. Patent No. 5,006,528 ("Carbostyril Derivatives," issued April 9, 1991) following a paragraph IV certification as part of Sun's filing of an ANDA to manufacture a generic version of Otsuka's Abilify® (aripiprazole, used to treat bipolar disorder and schizophrenia).  View the complaint here.

Janssen L.P. et. al. v. Barr Laboratories Inc. et. al.
3:07-cv-01515; filed March 30, 2007 in the District Court of New Jersey

Infringement of U.S. Patent No. 7,160,559 ("Controlled Release Galantamine Composition," issued January 9, 2007) following a paragraph IV certification as part of Barr's filing of an ANDA to manufacture a generic version of Janssen's Razadyne ER® (formerly Reminyl®) (galantamine hydrobromide, used to treat mild to moderate dementia of the Alzheimer's type).  View the complaint here.

Conference & CLE Calendar

April 13, 2007 - "Of Brics & Mortar: Technological Drivers in Booming Economies" Symposium (Northwestern Journal of Technology and Intellectual Property) - Chicago, IL

April 16-18, 2007 - Biotechnology: Patent Prosecution, Licensing, Litigation & Hatch-Waxman (Patent Resources Group) - Orlando, FL

April 19-20, 2007 - "Litigation and Enforcement in the Biotech and Pharmaceutical Industry" (GTCbio) - San Francisco, CA

April 27, 2007 - Patent Claim Construction Workshop (Law Seminars International) - Atlanta, GA

May 6-9, 2007 - BIO International Convention - Boston, MA

June 26-28, 2007 - Euro-Biotech Forum 2007 - Paris, France

Simcere Pharmaceuticals, NovaCardia, and Quark Biotech File for IPO's

    By Donald Zuhn ---

On March 23, 2007, Simcere Pharmaceuticals filed a registration statement with the Securities and Exchange Commission (SEC) for a proposed initial public offering of its common stock.  According to a MarketWatch report, the Chinese generic drug maker is seeking to raise $120 million in the IPO.  Simcere's shares will be listed on the New York Stock Exchange under the symbol "SCR."  On Thursday, Forbes.com reported that Simcere would be offering 15.6 million American Depositary Shares at an estimated price range of between $12.50 to $14.50 per share.  According to a Centient Biotech Investor report, Simcere posted a net profit of $22 million in 2006.

Simcere Pharma promotes itself as the leading manufacturer and supplier of branded generic pharmaceuticals in China.  Its product portfolio currently includes 35 drugs for the treatment of cancer, cerebrovascular and cardiovascular diseases, infections, arthritis, diarrhea, allergies, respiratory conditions, and urinary conditions.  Simcere plans to spend almost half of the expected IPO proceeds to fund its research and development efforts.

On March 29, 2007, NovaCardia Inc. announced that it filed a registration statement with the SEC for a proposed initial public offering of its common stock.  According to a StreetInsider.com report, the San Diego-based company is seeking to raise $86.3 million in the IPO.  NovaCardia's shares will be listed on the Nasdaq Global Market under the symbol "NCAR."

NovaCardia is a clinical-stage pharmaceutical company focused on developing drugs to treat major cardiovascular diseases.  NovaCardia has two compounds in clinical development: KW-3902, a selective adenosine A1 receptor antagonist for use in treating congestive heart failure, and K-201 (JTV-519), a compound NovaCardia licenses from Aetas Pharma Co. and which is used to treat atrial fibrillation.

On March 30, 2007, Quark Biotech Inc. filed a registration statement with the SEC for a proposed initial public offering of its common stock.  According to a MarketWatch report, while neither the number of shares in the offering nor the offering price have been determined, the pharmaceutical company is seeking to raise $86.25 in the IPO.  Quark's shares will be listed on the Nasdaq Global Market under the symbol "QURK."  Forbes.com has reported that Quark posted losses of $7.5 million in 2005 and $17 million in 2006.

Quark Biotech, based in Freemont, California, focuses on the development of synthetic short-interfering RNA therapeutics for the treatment of cancer and fibrotic diseases.  Among Quark's products are siRNA-based therapeutics for the treatment of neovascular (wet) Age-related Macular Degeneration (RTP801i-14, which inhibits expression of the hypoxia-inducible gene RTP801), acute renal failure  (AKIi-5, which temporarily inhibits expression of human p53), acute hearing loss (AHLi-11, which temporarily inhibits expression of human p53), and chronic obstructive pulmonary disease (CTi-1, which inhibits RTP801).  The company's patent portfolio includes thirteen U.S. patents and at least nine U.S. patent application publications.

For additional information about the rash of recent biotech and pharmaceutical IPO's, please see:

• "Aegerion Pharmaceuticals and Merrion Pharmaceuticals File for IPO's" - April 4, 2007

• "NimbleGen Files for IPO" - March 20, 2007

• "Biotech IPO's Down?" - March 1, 2007

Patent Profile: Oncolytics Announces Issuance of Neoplastic Cell Sensitization Patent

    By Donald Zuhn ---

On April 3, 2007, Oncolytics Biotech Inc. announced that it had been granted U.S. Patent No. 7,198,783.  The '783 patent, which relates to methods of sensitizing neoplastic cells to irradiation by using reoviruses, is the twentieth U.S. patent to be awarded to the Calgary-based biotech company.

According to the statement released by Oncolytics Biotech, the allowed claims "describe a method of using reovirus to sensitize Ras-activated cancer cells that are resistant to radiation therapy."  Chief Scientific Officer Dr. Matt Coffey characterized the '783 patent as "an important piece of intellectual property that supports our ongoing Phase II clinical program" using REOLYSIN®, Oncolytics' proprietary formulation of the human reovirus, in combination with radiation.

Reovirus (Respiratory Enteric Orphan virus) is found naturally in sewage and water supplies and inhabits human respiratory and bowel systems.  Because tumor cells bearing an activated Ras pathway lack dsRNA-activated protein kinase (PKR - protein kinase dsRNA), they are unable to activate a PKR-mediated anti-viral response.  As a result, such cells are susceptible to reovirus infection and subsequent cell death.  Normal cells, however, do not possess activating mutations of Ras, and thus, are able to terminate reovirus infection through normal PKR activity.

The '783 patent issued from U.S. Application No. 10/431,579 and claims the benefit of U.S. Provisional Application Nos. 60/378,948, filed May 10, 2002, and 60/443,189, filed January 29, 2003.  Representative independent claims 1 and 23 of the '783 patent recite:

1.  A method of sensitizing a ras-activated neoplastic cell to irradiation, wherein the neoplastic cell is resistant to an irradiating agent in the absence of reovirus, comprising:
    (a) determining whether the neoplastic cell is resistant to an irradiating agent in the absence of reovirus, wherein the determination indicates that the neoplastic cell is resistant to the irradiating agent in the absence of reovirus;
    (b) administering to said neoplastic cell an effective amount of a reovirus under conditions that result in infection of the cells by the reovirus; and
    (c) then subjecting said cell to an effective dose of the irradiating agent, whereby the sensitivity of the neoplastic cell to the irradiating agent is increased by the reovirus.

23.  A method of treating or ameliorating a tumor comprising ras-activated cells in a subject, comprising:
    (a) determining whether the tumor is resistant to an irradiating agent in the absence of reovirus, wherein the determination indicates that the tumor is resistant to the irradiating agent in the absence of reovirus;
    (b) administering to the subject an effective amount of a reovirus under conditions that result in infection of cells of the tumor by the reovirus; and
    (c) then irradiating the subject with an effective dose of an irradiating agent.

Lilly Completes Acquistion of Hypnion

    By Mark Chael ---

As we reported previously, Eli Lilly & Co. had been in the process of acquiring Hypnion, Inc. and its pipeline of insomnia drug candidates.  On Tuesday, Lilly announced that it had completed the acquisition, which has been valued at around $315 million.  With this acquisition, Lilly enhances its drug pipeline with HY10275, an insomnia drug candidate in Phase II trials, as well as several other early-stage candidates.

Unlike other insomnia drugs that target the GABA receptor, HY10275 acts on the histamine H1 and the serotonin 5HT2a receptors.  Drugs that affect the GABA receptor have a potential for abuse and are therefore classified as controlled substances, which therefore limits, in some respects, a physician's ability to prescribe such drugs.  It is unclear at present whether the U.S. Food and Drug Administration (FDA) will classify HY10275, and other drugs that target the H1 and 5HT2a receptors, as controlled substances.

Additional information regarding this story, including links to related patents and patent applications, prior press releases, and scientific information about the relevant receptors, can be found here.

Roche to Acquire BioVeris and Therapeutic Human Polyclonals

    By Jason Derry ---

On Wednesday, Roche announced that it would acquire BioVeris Corporation for about $600 million.  The purchase of BioVeris will allow Roche to expand its immunochemistry business into the life science research and development, drug discovery, and clinical research areas.

Roche's announcement that it would be acquiring BioVeris came two days after the company announced that it had acquired Therapeutic Human Polyclonals, Inc. for $56.5 million.  Therapeutic Human Polyclonals has developed transgenic rabbits in which human polyclonal antibodies can be developed, allowing Roche to expand its therapeutic antibody discovery and development program to include human polyclonal antibodies.

Aegerion Pharmaceuticals and Merrion Pharmaceuticals File for IPO's

    By Donald Zuhn ---

On March 21, 2007, Aegerion Pharmaceuticals Inc. filed a registration statement with the Securities and Exchange Commission (SEC) for a proposed initial public offering of its common stock.  According to a Reuters report, while neither the number of shares in the offering nor the offering price have been determined, Aegerion is seeking to raise $86.25 million in the IPO.  Aegerion's shares will be listed on the Nasdaq Global Market under the symbol "AEGR."  According to a TradingMarkets.com article, Aegerion posted losses of $1.4 million in 2005 - its first year of operation - and $6.2 million in 2006.

Aegerion Pharmaceuticals is a Bridgewater, New Jersey-based biopharmaceutical company focusing on the development of small-molecule therapeutics to treat cardiovascular and metabolic disease, and in particular, on inhibitors of microsomal triglyceride transfer protein (MTP).

On Monday, Merrion Pharmaceuticals Ltd. announced that it filed a registration statement with the SEC for a proposed initial public offering of its ordinary shares in the form of American Depositary Shares and ordinary shares.  The Dublin-based pharmaceutical company has applied to list its American Depositary Shares on the Nasdaq Global Market and its ordinary shares on the Irish Enterprise Exchange in Dublin, Ireland.  According to a Forbes.com article, Merrion is seeking to list both its American Depositary Shares and ordinary shares under the symbol "MERR."  According to a Reuters report, Merrion is looking to raise $46 million in the IPO.

Merrion Pharmaceuticals, established in 2004, develops oral therapeutics that can replace injectable drugs.  Merrion's primary focus is on its Gastrointestinal Permeation Enhancement Technology (GIPET) for oral delivery of poorly permeable drugs, and Gastrointestinal Retention System (GIRES) for the delivery of drugs having short half-lives and requiring extended local delivery to the gastrointestinal tract.  The company's patent portfolio includes two U.S. patents and U.S. Patent Application Publication No. 2006/0191239.