drug delivery technology

Biovail focuses on CNS drugs

Maureen Martino — Fri, 13 Jun 2008 12:34:15 -0400

As the battle for Biovail continues, current CEO William Wells emphasized the company's focus on CNS drug development at Goldman Sachs' annual healthcare conference. Biovail is investing $600 million over the next four years for work on epilepsy, multiple sclerosis, and Parkinson's. Wells said the company will "maintain its drug delivery technology but [will seek] to license it or use it for drug development."

Biovail's development plans, however, hardly seem to be the focus these day. Found Eugene Melnyk launched a proxy battle for the company recently and is looking to sweep out its board and senior management. Melnyk has a dissident group of shareholders backing him, while the current management urges shareholders to reject Melnyk's interference. The fight will come to a head at annual shareholder meeting on June 25, when shareholders vote on the company's future management.

- see the CNNMoney article

Avanti launches bionano company

Fri, 28 Mar 2008 07:59:54 -0400

Avanti Therapeutics launched a new bionanotechnology company for targeted drug delivery called Chikujee Therapeutics. Chikujee will use Avanti's drug delivery technology to enhance the performance of drugs, specifically anti-cancer drugs. The first drug classes the company will focus on are taxols (Paclitaxel and Docetaxel) and camptothecin for chemotherapy. Chikujee is Avanti's third early-stage company.

- here's the release

Related Articles:
Biotech says nano-device can directly target cancer cells. Report
MD considers funds for growing nano-biotech field. Report
Venture capitalists bet big on nanotechnology. Report
Nanotech is promising, but faces hurdles. Report

Melnyk slams Biovail board, calls for change

Fri, 29 Feb 2008 06:59:58 -0500

Biovail founder--and largest shareholder--Eugene Melnyk (photo) isn't happy with the company's management, and he's going to do something about it. In a scathing letter to shareholders, Melnyk lambastes the current board of directors for, as he says, not helping the company realize the full potential of its drug delivery technology.

After disappointing talks with the current board, Melnyk says he is exploring "various options available to me in connection with my interest in Biovail, including the possibility of joining with a partner or partners to acquire the remaining shares of Biovail, selling all or a portion of my current Biovail shares to a third party, continuing to hold my shares for investment, or seeking changes to the composition of the Board of Directors."

Melnyk stepped down as chairman in June of 2007 as part of a settlement with Canadian regulators who were investigating insider trading allegations linked to his sale of $1.3 billion in Biovail stock between 2002 and 2004. Melnyk currently owns 11 percent of the company's stock.

- read Melnyk's letter
- see this Financial Post article for more

Related Articles:
Biovail drug launch draws feds' scrutiny. Report
Biovail shares sink after FDA schedules review. Report
FDA hands Biovail a non-approval letter. Report
Biovail's Melnyk to step down amid SEC probe. Report

MediQuest touts Phase III Raynaud's data

Fri, 09 Nov 2007 06:59:57 -0500

MediQuest Therapeutics is reporting positive results from a Phase III trial of MQX-503, a topical therapy for Raynaud's Disease. Raynaud's--a stinging constriction of blood flow to hands, feet and other extremities that affects mostly women--has an estimated market potential of more than $300 million. Patients taking MQX-503 showed significant improvements in their condition.

"With the conclusion of this clinical study, MediQuest is one step closer to submitting the MQX-503 New Drug Application to the FDA," said Dr. Frederick Dechow, MediQuest president and CEO. "Our proprietary drug delivery technology provides a unique platform to deliver active therapeutic agents to specific problem areas. MQX-503 is a new therapy specifically designed to treat this unmet clinical need."

- check out the release from MediQuest
- see this Emerging Drug Developer profile for more

ALSO NOTED: University spins off drug delivery company; Millennium Phase II meets goal; Will the FDA get money to flex muscles?

Wed, 07 Nov 2007 06:59:50 -0500

> The University of Leuven has spun off Formac Pharmaceuticals, banking on new drug delivery technology to tackle poorly soluble molecules. Release | Report

> A Phase II trial of Millennium Pharmaceuticals' MLN1202 met its primary endpoint of reducing C-reactive protein levels in patients at high-risk for atherosclerotic cardiovascular disease. MLN1202 is a novel, humanized monoclonal antibody. Release

> Sure enough, President Bush announced yesterday that he'd like to pump up the power at the FDA, but said not a word on increased funding for the effort. Report

> Norway's SantoSolve raised $7 million in a new venture round, enough money to push its lead pain therapy, 2PX, into a late stage study. Release

> Biovail has acquired marketing rights to two early stage therapies from Pharma Pass II. Report

> Kiadis Pharma's lead product, ATIR, has been granted orphan drug designation by the FDA as a therapy for immune reconstitution and prevention of Graft versus Host Disease (GvHD) following allogeneic bone marrow transplantation. ATIR is currently in phase I/II clinical studies and anticipated to enter clinical phase III studies in 2008. Release

> Apitope Technology has completed dosing six multiple sclerosis patients in a Phase I/IIa trial of ATX-MS-1467. The therapeutic vaccine was found to be safe and well tolerated. Release

> A federal judge dealt a blow to Johnson & Johnson's trademark-infringement suit against the American Red Cross. Report

> Neural stem cells were used to stimulate the learning and memory abilities of mice engineered to mimic the severe disabilities produced by Alzheimer's and stroke. Report

> A chemistry professor at the University of Illinois at Urbana-Champagne says that an iron-based catalyst she developed with a colleague could speed the drug delivery and manufacturing process. Report

And Finally... Here's a little secret about Eli Lilly's U.S. president Deidre Connelly (photo): She likes to go undercover. Report

QLT gains drug delivery tech in $42M buyout

Tue, 09 Oct 2007 06:59:55 -0400

Canada's QLT has snapped up new drug delivery technology for eye conditions with its $42 million acquisition of ForSight Newco II. The deal also includes $40 million in scheduled milestones for the development and commercialization of the new technology, called "punctual plugs."

"This acquisition is a clear strategic fit. It complements our expertise in ophthalmology, and it supports our goal to expand our pipeline of ocular products," said Bob Butchofsky, president and CEO of QLT.

- see QLT's release

Related Articles:
QLT says therapy fails Phase II trial. Report
QLT slashes spending as competition looms. Report
QLT shares drop after eye drug flunks vision-loss trial. Report

SkyePharma shares dented by Flutiform delay

Mon, 06 Aug 2007 06:59:58 -0400

Shares of SkyePharma took a nasty hit this morning after the company revealed that it would need to provide more data to the FDA on its asthma drug. That move could delay an NDA on Flutiform until the second half of next year, which didn't please investors one whit. SkyPharma promised more details once it has received some additional clarification from the agency, adding that the delay would likely drive up its development costs by $6 million to $10 million dollars (it sounds much less these days when translated into £3 million to £5 million). Last spring the agency approved a new asthma treatment--Zyflo--that uses the UK company's drug delivery technology.

- read the report on SkyePharma from the International Herald Tribune

Related Articles:
SkyePharma gets long-awaited Flutiform partner. Report
Skyepharma opens books to interested suitors. Report
Zyflo flunks mid-stage study for severe acne. Report

SurModics paying up to $62M for Brookwood

Wed, 01 Aug 2007 06:59:57 -0400

The Southern Research Institute has sold Brookwood Pharmaceuticals to SurModics for $40 million up front and up to $22 million in milestones. Both SurModics and Brookwood specialize in drug delivery technologies. Brookwood was created two years ago and its 70 employees are expected to stay put in Birmingham, AL. "While we will miss having Brookwood as part of our extended organization, we are convinced that these two combined companies will be much more successful than they would apart," said Southern Research CEO Jack Secrist.

- check out the release
- here's the report from the Birmingham News

Related Articles:
Merck pays $308M deal for SurModics delivery platform. Report
Drug delivery vehicles' shape could determine efficacy. Report
Nanoparticle developed for new drug delivery system. Report

ALSO NOTED: Elbion acquires drug candidates; Vanda looks to raise $96M;and much more...

Thu, 18 Jan 2007 19:01:30 -0500

> Belgium's Elbion NV has acquired some late-stage drug candidates from DrugAbuse Sciences. Two of the therapies are sustained-release forms of currently approved drug. Naltrexone Depot, an antagonist that blocks receptors in the brain and is used in the treatment of opiate and alcohol abuse, is expected to head into Phase III this year. Buprenorphine Depot, a sustained release buprenorphine indicated for the treatment of opiate addiction, is also included in the portfolio. No financial terms were disclosed. Release

> Shares of Vanda Pharmaceuticals were on the rise after it announced that it had priced an offering of 3.8 million shares at $27.29. The offering is designed to raise about $96 million. Vanda has been developing therapies for CNS diseases. Late last year Vanda confirmed positive data from a Phase III trial of its experimental insomnia drug, VEC-162. Report

> Bayer Innovation has licensed the rights to DelSiTech's drug delivery technology for fiber applications in the fields of wound care and certain other applications. Release

And Finally… A number of medical schools are prohibiting their students from taking advantage of the free lunches and other freebies offered by drug reps. Report

Press Release: Nastech Pharmaceutical Company To Get $42.9M In 3.25M Stake Offer

Maureen Martino — Thu, 18 Jan 2007 09:20:12 -0500

Nastech Pharmaceutical Company To Get $42.9 Million In 3.25 Million Stake Offer

BOTHELL, Wash., Jan. 18 -- Nastech Pharmaceutical Company Inc. today announced the pricing of an underwritten public offering of 3.25 million shares of its common stock at an estimated total public offering price of up to approximately $42.9 million. The offering is being made pursuant to a shelf registration that became effective on November 29, 2006. All of the shares are being sold by Nastech. UBS Investment Bank acted as sole bookrunner for the offering. The Company has granted the underwriter an option to purchase up to an additional 487,500 shares to cover over-allotments in the offering, if any.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state. A prospectus supplement and the accompanying base prospectus relating to these securities will be filed with the Securities and Exchange Commission (the "SEC") and will be available on the SEC's website at http://www.sec.gov. This offering of shares of common stock may be made only by means of the prospectus supplement and accompanying base prospectus, a copy of which can be obtained upon request in writing to UBS Securities LLC, 299 Park Avenue, New York, NY 10171, Attn: Equity Syndicate Desk.

About Nastech

Nastech is a pharmaceutical company developing innovative products based on proprietary molecular biology-based drug delivery technologies. Nastech and its collaboration partners are developing products for multiple therapeutic areas including osteoporosis, diabetes, obesity, respiratory diseases and inflammatory conditions.

Contacts: Nastech Pharmaceutical Company Inc. Ed Bell Senior Investor Relations Manager (425) 908-3639 ir@nastech.com Noonan Russo Matthew Haines (Investors/Media) (212) 845-4235

Nastech Pharmaceutical Company Inc.
CONTACT: Ed Bell, Senior Investor Relations Manager of NastechPharmaceutical Company Inc., +1-425-908-3639, ir@nastech.com; orInvestors/Media: Matthew Haines of Noonan Russo, +1-212-845-4235

Press Release: AlphaRx Inc. Provides Positive Update On Indaflex

Maureen Martino — Wed, 10 Jan 2007 10:41:03 -0500

AlphaRx Inc. Provides Positive Update On Indaflex

MARKHAM, Ontario, Jan. 9, 2007 -- AlphaRx Inc. is pleased to announce that Proprius Pharmaceuticals Inc. has raised up to $17M in a Series A financing. A large portion of the proceeds will be used to complete the Phase II trial of Indaflex(tm) and advance Indaflex(tm) towards pivotal Phase III trials later this year.

About Indaflex(tm)

Indaflex(tm) is a topical NSAID (Non-Steroidal Anti-inflammatory Drug) formulation currently in Phase II clinical development for the reduction of signs and symptoms associated with OA of the knee. Arthritis is the most common chronic disease in North America and afflicts an estimated 10% of the world's population. The active ingredient in Indaflex(tm), indomethacin, has a long-standing and proven clinical treatment record. Delivered through the skin using proprietary technology developed by AlphaRx, the companies believe Indaflex(tm) will have an attractive safety, tolerability and efficacy profile in comparison to oral treatments and other topical preparations.

About AlphaRx Inc.

AlphaRx is a clinical stage biopharmaceutical company utilizing proprietary drug delivery technology to develop novel formulations of drugs that are insoluble or poorly soluble in water or have yet to be administrable to the human body with an acceptable delivery method. The Company's product candidates address various pharmaceutical markets, including arthritis, tuberculosis, ocular infection and inflammation, pneumonia and sepsis.

Forward-Looking Statements:

This release contains forward-looking statements within the meaning and pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995 and involve risks and uncertainties that may individually or mutually impact the matters herein described, including but not limited to product development and acceptance, manufacturing, competition, regulatory and/or other factors, which are outside the control of the companies.

CONTACT: For AlphaRx Inc.: AGORACOM Investor Relations Corp. http://www.agoracom.com ALRX@Agoracom.com

Press Release: pSivida Limited Signs Drug Delivery Licensing Agreement With Faber Research

Maureen Martino — Tue, 09 Jan 2007 11:04:08 -0500

pSivida Limited Signs Drug Delivery Licensing Agreement With Faber Research; Payments Totalling US $990K

BOSTON & PERTH, Australia -- Global bio-nanotech company pSivida Limited today announced it has entered into a licensing agreement with US-based Faber Research LLC (Faber) to develop pSivida's proprietary Durasert(TM), Zanisert(TM) and Co-Drug(TM) drug delivery technologies for infectious diseases and diseases of the ear.

This announcement follows an announcement on December 26, 2006 that pSivida entered into an exclusive negotiation period with a major global pharmaceutical company to acquire a worldwide, royalty bearing license to make, use and sell products using pSivida's drug delivery technologies. The pharmaceutical company will make payments totalling US$990k (AU$1.3m) to pSivida for the right to exclusively negotiate a licensing agreement with the Company for a period of three months and to fund the cost of a preclinical study. The commencement of licensing negotiations follows a 12 month evaluation of pSivida's technologies by the large global pharmaceutical company.

Under the terms of the Faber license, Faber receives exclusive rights to pSivida's technologies for diseases of the ear and for five specific infectious diseases, namely malaria, HIV/AIDS, influenza, tuberculosis, and osteomyelitis. All costs of development will be born by Faber and its operating company Auritec Pharmaceuticals Inc (Auritec) and pSivida will receive royalties and milestone payments.

In addition, pSivida has granted Faber co-exclusive rights to the Durasert(TM), Zanisert(TM) and Co-Drug(TM) drug delivery technologies for other infectious diseases. Under this arrangement pSivida and Faber can elect to convert their co-exclusive rights to exclusive rights for a specific infectious disease indication(s). pSivida believes this maximizes the potential to commercialize these technologies in the development of novel anti-infective drugs, a market that reached (a)US$44 billion in 2005.

pSivida's Durasert(TM) controlled release technology is already validated in that it forms the basis of the company's ophthalmic drug delivery products, Retisert(TM), which is FDA approved, and Medidur(TM), which is currently in Phase III clinical trials.

Auritec has developed novel approaches to extended release drug delivery with implications for indications including: HIV microbicides, the treatment of malaria and the prevention of pandemic influenza. Auritec also has an active program for the delivery of drugs to the inner ear.

Dr. Roger Brimblecombe, Chairman and CEO at pSivida said, "We believe this represents a significant opportunity for our drug delivery technologies to be exploited in another therapeutic area - that of infectious diseases and it will be done at no direct cost to us."

Dr. Thomas J Smith, MD, Chairman and Chief Executive Officer at Auritec said, "We look forward to the opportunities for synergies between our companies in the treatment of infectious diseases."

Dr William H. Slattery, MD, Clinical Professor of Otolaryngology at the University of Southern California, and Director of Otology Research at Auritec said, "The ability to utilize pSivida's drug delivery technologies will accelerate our otology program significantly."

Faber Research LLC and Auritec Pharmaceuticals

Faber is the intellectual property holding company for Auritec, a private company based in Pasadena, California, specializing in innovative, extended release drug delivery systems. Auritec was co-founded by Dr. Thomas J Smith, MD, who was previously Chairman and co-founder of Control Delivery Systems, Inc., the Boston, MA. based drug delivery company pSivida acquired in January 2006.

(a) CHA Advances Reports, 2006

NOTES TO EDITORS:

pSivida is a global bio-nanotech company committed to the biomedical sector and the development of drug delivery products. pSivida has developed proprietary drug delivery technology which it had previously referred to as its AEON technology. pSivida now has identified two somewhat distinct avenues for such technology: non-biodegradable implants for focused drug delivery (Durasert(TM)) and biodegradable implants for focused drug delivery (Zanisert(TM)).

Retisert(TM) is FDA approved for the treatment of uveitis. Vitrasert® is FDA approved for the treatment of AIDS-related CMV Retinitis. Bausch & Lomb own the trademarks Vitrasert® and Retisert(TM). pSivida has licensed the technologies underlying both of these products to Bausch & Lomb. The technology underlying Medidur(TM) for diabetic macular edema is licensed to Alimera Sciences and is in Phase III clinical trials.

pSivida owns the rights to develop and commercialize a modified form of silicon (porosified or nano-structured silicon) known as BioSilicon(TM), which has applications in drug delivery, wound healing, orthopedics, and tissue engineering. pSivida's subsidiary, AION Diagnostics Limited is developing diagnostic products and the subsidiary pSiNutria is developing food technology products both using BioSilicon(TM).

pSivida's intellectual property portfolio consists of 76 patent families, 95 granted patents, including patents accepted for issuance, and over 300 patent applications. pSivida conducts its operations from offices and facilities near Boston in the United States, Malvern in the United Kingdom, Perth in Australia and Singapore.

pSivida is listed on NASDAQ (PSDV), the Australian Stock Exchange (PSD) and on the Frankfurt Stock Exchange on the XETRA system (German Symbol: PSI. Securities Code (WKN) 358705). pSivida is a founding member of the NASDAQ Health Care Index and the Merrill Lynch Nanotechnology Index.

This document contains forward-looking statements that involve risks and uncertainties including with respect to Faber's development of pSivida's technologies for infectious diseases and disease of the ear; the major global pharma's acquiring a license to pSivida's drug delivery technology; the potential signing of definitive agreements with Nordic on the terms described; the amount of pSivida's portion of the costs to develop Medidur(TM) for DME; the potential size of certain markets; and potential products, applications and regulatory approvals. Although we believe that the expectations reflected in such forward-looking statements are reasonable at this time, we can give no assurance that such expectations will prove to be correct. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. Actual results could differ materially from those anticipated in these forward-looking statements due to many important factors including:

The failure of Faber to develop pSivida's drug delivery technologies for infectious diseases and diseases of the ear; failure of the election to convert co-exclusive rights to exclusive rights to maximize the potential to commercialize pSivida's technologies in the development of novel anti-infective drugs; inability of any products developed under the license to Faber to penetrate the novel anti-infective drug market; failure of novel anti-infective drug market to continue to remain at US$44 billion; failure of Auritec's novel approaches to extended release drug delivery to have implications for indications including; HIV microbicides, the treatment of malaria and the prevention of pandemic influenza; failure of Auritec to continue its active program for the delivery of drugs to the inner ear; the failure of the company to successfully negotiate and sign a license agreement with the major global pharma on advantageous terms or at all; failure of the ongoing evaluation with the major global pharma to produce favorable results; failure of the focus of the preclinical study to be in a very significant product opportunity; failure of the company to successfully close the transaction with Nordic contemplated by the MOUs with Nordic; the failure of the Company to obtain the requisite shareholder approvals to complete the Nordic transactions; failure of pSivida's share of Medidur(TM) development costs to be no more than US$22m; failure of the results of the Retisert(TM) for DME trial to be a good indicator of the results of pSivida's ongoing Phase III Medidur(TM) for DME trial; failure of the Medidur(TM) trials in DME to show a very similar improvement in visual acuity and diabetic retinopathy severity score as Retisert(TM) for DME; failure of Medidur(TM) to release fluocinolone acetonide at the same rate as Retisert(TM); our inability to recruit patients for the Phase III Medidur(TM) for DME trial; our inability to raise additional funds at favorable terms or any terms; our inability to repay the amended notes and new convertible notes; our inability to develop proposed products, including without limitation, in the drug delivery, wound healing, orthopaedics, and tissue engineering, diagnostics and food technology fields; failure of our evaluation agreements to produce favorable results and/or result in license agreements; failure to develop applications for BioSilicon(TM) due to regulatory, scientific or other issues; failure to complete negotiations for new centers for the BrachySil(TM) Phase IIb clinical trial for inoperable primary liver cancer; failure of our discussions with the FDA for BrachySil(TM) to continue or to lead to FDA approval; failure of the BrachySil(TM) Phase IIb clinical trial for inoperable primary liver cancer to determine the optimal dose, provide key safety data or support future pivotal efficacy trials or product registration or approval; failure of the BrachySil(TM) primary liver program that is in Phase IIb clinical trials to provide a valuable platform for the development and commercialization of BrachySil(TM) for pancreatic cancer and other indications; failure of the findings of the pancreatic cancer Phase IIa trial to provide a platform for further multicenter efficacy and safety trials; and failure of there to be optimization and standardization between our two pancreatic cancer study centers. Other reasons are contained in cautionary statements in the Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission, including, without limitation, under Item 3.D, "Risk Factors" therein. We do not undertake to update any oral or written forward-looking statements that may be made by or on behalf of pSivida.

Contact: pSivida Limited Brian Leedman, + 61 412 281 780 Director of Investor Relations brianl@psivida.com or Martin E. Janis & Company, Inc US Public Relations Beverly Jedynak, 312-943-1100 ext. 12 President bjedynak@janispr.com or Accent Marketing Limited European Public Relations Eva Reuter, +49 (254) 393 0740 e.reuter@e-reuter-ir.com or For Auritec Auritec Pharmaceuticals Gary Ransom, 626-376-4070 Vice-President Corporate Development gransom@auriecpharma.com www.auritecpharma.com or Oak Crest Institute of Science US Public Relations Sayuri D. Hanna, 626-817-0886 s.hanna@oak-crest.org

ALSO NOTED: Medicines Company gets positive safety data; InterMune gains $10M payday; and much more...

Mon, 08 Jan 2007 19:01:30 -0500

> The Medicines Company announced that three late-stage safety trials of Cleviprex, an experimental drug for severe high blood pressure, met their specified objectives. Release

> InterMune has pocketed a $10 million milestone payment from its pact with Roche on an experimental hepatitis C therapy. Release

> Genentech has agreed to pay an unspecified amount for an entire oncology program for a target run by Amphora. Release

> Australia's pSivida has struck a licensing deal with Faber Research to develop pSivida's drug delivery technologies for infectious diseases and diseases of the ear. Faber receives exclusive rights to pSivida's technologies for diseases of the ear and for five specific infectious diseases. All costs of development will be born by Faber and its operating company Auritec Pharmaceuticals. Release

> Osiris Therapeutics has won the FDA's fast track status for its stem cell treatment for Crohn's Disease. Release

> India's Ranbaxy expressed an interest in bidding for Merck KGaA's generic drug unit. Report (WSJ sub. req.)

And Finally... Japanese scientists have developed a technique to gauge a person's thoughts by changes in the blood flow of his brain. Report

Press Release: Skyepharma Announces FDA Approves Foradil Certihaler

Maureen Martino — Sun, 17 Dec 2006 09:33:47 -0500

Skyepharma Announces FDA Approves Foradil Certihaler

London, UK -- Dec 18, 2006 -- LONDON, UK, 18 December 2006 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP) announces today that the US Food and Drug Administration (FDA) has approved FORADIL® CERTIHALER(TM) (formoterol fumarate inhalation powder) for the treatment of asthma. FORADIL® CERTIHALER(TM) has been co-developed by SkyePharma and Novartis, and is a trademark of Novartis.

The FDA issued an "approvable" letter for FORADIL® CERTIHALER in April 2006. Following a recall from the German and Swiss markets in January 2006 because of concerns that accidental mishandling of the device may have resulted in inaccurate dosing in a small number of cases. The device was modified and the modifications were submitted to the FDA.

The Foradil® Certihaler(TM) has been approved in 27 countries outside the USA, and SkyePharma is in discussion with Novartis with respect to commercial launch in these territories.

SkyePharma earns a royalty on sales of FORADIL® CERTIHALER(TM) in all markets. SkyePharma also manufactures and supplies the FORADIL® CERTIHALER(TM).

Frank Condella, CEO, SkyePharma said:

"We are extremely pleased by the FDA's decision to approve the modifications to FORADIL® CERTIHALER(TM). We believe that this approval validates SkyePharma's inhalation technology and paves the way to future products."

For further information please contact:

SkyePharma PLC +44 207 491 1777 Frank Condella, Chief Executive Officer Ken Cunningham, Chief Operating Officer Buchanan Communications +44 207 466 5000 Tim Anderson / Mark Court / Rebecca Skye Dietrich The Trout Group + 1 617 583 1308 Seth Lewis Notes for editors

About SkyePharma

SkyePharma PLC develops pharmaceutical products benefiting from world-leading drug delivery technologies that provide easier-to-use and more effective drug formulations. There are now eleven approved products incorporating SkyePharma's technologies in the areas of oral, injectable, inhaled and topical delivery, supported by advanced solubilisation capabilities. For more information, visit www.skyepharma.com.

Certain statements in this news release are forward-looking statements and are made in reliance on the safe harbour provisions of the U.S. Private Securities Litigation Act of 1995. Although SkyePharma believes that the expectations reflected in these forward-looking statements are reasonable, it can give no assurance that these expectations will materialize. Because the expectations are subject to risks and uncertainties, actual results may vary significantly from those expressed or implied by the forward-looking statements based upon a number of factors, which are described in SkyePharma's 20-F and other documents on file with the SEC. Factors that could cause differences between actual results and those implied by the forward-looking statements contained in this news release include, without limitation, risks related to the development of new products, risks related to obtaining and maintaining regulatory approval for existing, new or expanded indications of existing and new products, risks related to SkyePharma's ability to manufacture products on a large scale or at all, risks related to SkyePharma's and its marketing partners' ability to market products on a large scale to maintain or expand market share in the face of changes in customer requirements, competition and technological change, risks related to regulatory compliance, the risk of product liability claims, risks related to the ownership and use of intellectual property, and risks related to SkyePharma's ability to manage growth. SkyePharma undertakes no obligation to revise or update any such forward-looking statement to reflect events or circumstances after the date of this release.

Press Release: Lipoxen Announces $75M Agreement With Baxter

Maureen Martino — Thu, 14 Dec 2006 10:35:13 -0500

Lipoxen Announces $75M Agreement With Baxter to Develop New Blood Clotting Factors

LONDON, December 15 -- Lipoxen PLC (LSE: LPX - News) today announced that the company has entered into an exclusive worldwide development and licence agreement with a subsidiary of Baxter International Inc. to develop improved, longer-acting forms of blood-clotting factors.

The signing of this agreement by Baxter triggers a $1 million payment to Lipoxen, and the agreement includes further clinical and regulatory milestone payments to Lipoxen potentially worth up to a total of $75 million, plus royalties on future product sales.

This announcement follows a 12-month research evaluation announced 15 August, 2005, that focused on linking Lipoxen's PolyXen® drug delivery technology with Baxter's proprietary proteins.

Lipoxen's PolyXen® protein drug delivery technology links therapeutic proteins, or peptides, to the naturally occurring polymer polysialic acid to prolong protein stability and biological half-life, and to improve solubility and immunological characteristics while maintaining biological activity and minimizing toxicity. Conjugating PolyXen® to therapeutic blood-clotting factors aims to improve pharmacokinetic profile and extend active life in order to reduce the frequency of injections required to treat blood-clotting disorders such as haemophilia A. M. Scott Maguire, CEO of Lipoxen, said: "We are very excited to sign this significant agreement with Baxter, our second major development agreement in the past year. Over the course of the 12-month evaluation period, our PolyXen® technology has indicated its potential for improving the delivery and effectiveness of Baxter's proprietary proteins and thereby represents an important validation of this protein drug delivery technology."

"Our agreement with Lipoxen furthers Baxter's legacy of scientific innovation and leveraging partnerships in the area of blood-free recombinant protein processing," said Hartmut J. Ehrlich, MD., Vice President, global research and development, for Baxter's BioScience business. "Extending the duration of a blood-clotting treatment in the body is important for both patients and physicians when evaluating haemophilia therapy."

Earlier this week at the American Society of Hematology 48th annual meeting, Baxter presented preclinical data from ongoing research studies aimed at developing a novel, longer-acting form of factor VIII, a protein essential for the normal clotting of blood. Baxter will continue to conduct preclinical research before moving these programs forward to clinical trials.

Notes to Editor

Lipoxen PLC (LSE:LPX - News) is a biopharmaceutical company specializing in the development of high value differentiated biologicals, vaccines and oncology drugs. Potential products, which address markets in excess of US$1 billion, currently under development include improved formulations of important biologicals including EPO, G-CSF, insulin and Interferon-alpha based on Lipoxen's proprietary PolyXen® technology. This technology is designed to improve the stability, biological half-life and immunologic characteristics of therapeutic proteins naturally. Lipoxen has two further naturally-derived proprietary delivery technologies ImuXen® and a related liposomal technology for the formulation of cytotoxic oncology drugs, which are being developed to enhance the efficacy and safety of various vaccines such as Hepatitis B and pneumococcal vaccines, as well as a number of anti-cancer agents like paclitaxel. The Company's proprietary delivery technologies are attracting significant interest and Lipoxen is already co-developing products with The Serum Institute of India, one of the world's leading vaccine companies. In addition, its technologies are being currently evaluated by leading biotechnology companies such as Baxter, Amgen, Genzyme and Genentech.

Lipoxen was admitted to trading on the AIM Market of the London Stock Exchange in January 2006.

This announcement includes 'forward-looking statements' which include all statements other than statements of historical facts, including, without limitation, those regarding the Company's financial position, business strategy, plans and objectives of management for future operations (including development plans and objectives relating to the Company's products and services), and any statements preceded by, followed by or that include forward-looking terminology such as the words 'targets', 'believes', 'estimates', 'expects', 'aims', 'intends', 'will', 'can', 'may', 'anticipates', 'would', 'should', 'could' or similar expressions or the negative thereof. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors beyond the Company's control that could cause the actual results, performance or achievements of the Company to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. Such forward-looking statements are based on numerous assumptions regarding the Company's present and future business strategies and the environment in which the Company will operate in the future. Among the important factors that could cause the Company's actual results, performance or achievements to differ materially from those in forward-looking statements include those relating to The Company's funding requirements, regulatory approvals, clinical trials, reliance on third parties, intellectual property, key personnel and other factors. These forward-looking statements speak only as at the date of this announcement. The Company expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained in this announcement to reflect any change in the Company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, readers are cautioned not to rely on any forward-looking statement.

Halozyme shares soar on major licensing pact

Tue, 05 Dec 2006 19:01:38 -0500

News that Roche has licensed Halozyme Therapeutics' drug delivery technology--Enhanze--in a deal worth up to $581 million sent Halozyme's stock up a whopping 60 percent. Halozyme gains $20 million up front for Roche's use of the technology for three specific drug targets and has an option to commercialize the technology on another 10 therapies over 10 years. Milestone payments on the first three programs could be worth up to $111 million with another $47 million on each of the next 10 programs. And Roche is investing $11 million in Halozyme, gaining a 5 percent stake of its common shares. Analysts liked the terms, noting that the pact marks a critical validation for Halozyme's work.

- see the press release on the pact
- here's the AP report on the deal

Related Articles:
Roche walks away from daclizumab pact. Report
InterMune inks major collaboration with Roche. Report

Press Release: Halozyme and Roche Enter Agreement for the Application of Enhanze

Maureen Martino — Tue, 05 Dec 2006 11:13:14 -0500

Halozyme and Roche Enter Agreement for the Application of Enhanze, A Novel Technology to Improve Drug Delivery

BASEL, Switzerland and SAN DIEGO, Dec. 5 -- Halozyme Therapeutics, Inc. (Amex: HTI - News) and Roche today announced they have entered into an agreement to apply Halozyme's proprietary Enhanze(TM) Technology to Roche's biological therapeutic compounds. Enhanze Technology is Halozyme's proprietary drug delivery technology based on its recombinant human hyaluronidase (rHuPH20). rHuPH20 is an analogue of a human enzyme that temporarily clears space in the matrix of tissues such as skin. This clearing activity should allow rHuPH20 to improve drug delivery by enhancing the entry of therapeutic molecules through the subcutaneous space.

"Roche is a global leader in the development of biologics and we are excited to be applying our rHuPH20 technology to this area with Roche compounds," said Jonathan Lim, MD, Halozyme's President and CEO. "We believe that our technology can enhance the clinical benefits that biologics have already been shown to provide. In every respect, both technically and commercially, this represents a landmark agreement for Enhanze Technology and for Halozyme."

"We are looking forward to working together with Halozyme using their rHuPH20 technology," said Peter Hug, Roche's Global Head of Pharma Partnering. "The potential to improve the administration and bioavailability of subcutaneous medicines presents an important advance to make a difference to patients' lives."

Halozyme Roche Collaboration

Under the terms of the agreement, Roche will pay Halozyme $20 million as an initial upfront payment for the application of rHuPH20 to three pre-defined Roche biologic targets. Over the next ten years, Roche will also have the option to exclusively develop and commercialize rHuPH20 with an additional ten targets. Pending the successful completion of a series of clinical, regulatory, and sales events, Roche may pay Halozyme further milestones which could potentially reach a value of up to $111 million as well as royalties on potential product sales for the first three targets. For each of the additional ten targets, Roche may pay Halozyme further upfront and milestone payments of up to $47 million per target. In addition, the Roche Venture Fund will make an $11 million equity investment, representing approximately 5% of Halozyme's outstanding common stock.

Under the collaboration, Roche will also obtain access to Halozyme's expertise in developing and applying rHuPH20 to Roche targets. Roche will obtain a worldwide, exclusive license to develop and commercialize product combinations of rHuPH20 and Roche target compounds resulting from the collaboration.

About Enhanze Technology

Enhanze Technology is Halozyme's proprietary drug delivery technology based on recombinant human hyaluronidase (rHuPH20), a recombinant form of the naturally occurring human enzyme approved by FDA for its ability to break down hyaluronic acid (HA), the space-filling "gel"-like substance that is a major component of tissues throughout the body. When combined or co-formulated with certain injectable drugs, Enhanze Technology can act as a "molecular machete" to facilitate the penetration and dispersion of these drugs by temporarily opening flow channels under the skin. Molecules as large as 200 nanometers may pass freely through the perforated extracellular matrix, which recovers its normal density within approximately 24 hours, leading to a drug delivery platform which does not permanently alter the architecture of the skin.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, a leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2005 sales by the Pharmaceuticals Division totaled 27.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (www.roche.com) or in the U.S. (www.roche.us).

About the Roche Venture Fund

The Roche Venture Fund advises Roche on investments in early stage biotech and diagnostics companies to support innovative technologies and medicines. Based in Basel, Switzerland, the Roche Venture Fund manages a portfolio of over 25 companies in 10 countries.

About Halozyme

Halozyme is a biopharmaceutical company developing and commercializing recombinant human enzymes for the drug delivery, palliative care, oncology, and infertility markets. The company's portfolio of products is based on intellectual property covering the family of human enzymes known as hyaluronidases. Halozyme's recombinant human enzymes may replace current animal slaughterhouse-derived extracts that carry potential risks of animal pathogen transmission and immunogenicity. The company has received FDA approval for two products: Cumulase®, the first and only recombinant human hyaluronidase for cumulus removal in the IVF process; and Hylenex for use as an adjuvant to increase the absorption and dispersion of other injected drugs. The versatility of the first enzyme, rHuPH20, enables Halozyme to develop the product as a medical device, drug enhancement agent, and therapeutic drug.

Conference Call

Halozyme management will host a conference call on Wednesday, December 6, 2006 at 11:00AM Eastern Time to discuss the contents of this press release in more detail. To participate via telephone, please call 888-463-4487 for domestic callers, or 706-679-5355 for international callers. A telephone replay will be available for 48 hours by dialing 800-642-1687 from the U.S., or 706-645-9291 for international callers, and entering reservation number 3270440. The conference call will be broadcast live over the Internet at www.halozyme.com and will be available for 30 days.

Forward-Looking Statements

This press release contains forward-looking statements. Such forward-looking statements, include, among others, those relating to the successful development, approval and launch of a product using rHuPH20; the potential receipt by Halozyme of substantial payments by successfully fulfilling certain development and commercial milestones; that a compound using rHuPH20 will be successfully developed and approved as a product which may be sold to the public; that Halozyme will receive royalties from sales of this product, if successfully launched and that this product, if developed, could represent a significant step forward in treating patients. These statements are based on current expectations of future events. Forward-looking statements are not guarantees of performance. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from expectations and projections. These forward looking statements are subject to numerous risks and uncertainties. These risks and uncertainties include but are not limited to, general industry conditions and competition; obtaining U.S. and other countries regulatory approvals; health care changes in the U.S. and other countries; unexpected outcomes; product efficacy or safety concerns; product manufacturing issues; successful marketing of the product if developed; superior products being brought to market; loss of key employees; government reimbursement issues; economic conditions; technological advances and patents attained by competitors; manufacturing and supply disruptions; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents by competitors or allegations that the product infringes the patents of third parties; U.S. and other countries health care reforms; governmental laws and regulations; product liability claims or litigation risks; governmental investigations; and trends toward health care cost containment. These risks and uncertainties also include the risks that clinical trials may not proceed as planned due to technical, scientific, or patient enrollment issues, or disagreements with regulatory authorities over trial design or other matters; that the scale and scope of future clinical and nonclinical studies may change and will be determined in significant part by data collected in ongoing and future trials; that further clinical studies may not reflect the results obtained in early clinical and nonclinical studies; that ongoing nonclinical studies, including toxicology studies, will yield currently unanticipated negative outcomes that could adversely affect planned clinical trials; that results from the clinical trials will be insufficient to support additional phase programs without additional trials and consequent delay in the timetable for potential approval; and that any potential product may not achieve sales sufficient to earn the royalties referenced above. The foregoing list sets forth many, but not all, of the factors that could impact upon the ability to achieve results described in any forward-looking statements. It is not possible to predict or identify all such factors and should not consider this list to be a complete statement of all potential risks and uncertainties. Neither company assumes any obligation to update any forward-looking statements as a result of new information or future events or developments.

Press Release: Alimera Sciences Completes Second Tranche of Series B Financing

Maureen Martino — Sun, 26 Nov 2006 12:43:14 -0500

Alimera Sciences Completes Second Tranche of Series B Financing, Receives $15.9 Million

ATLANTA, November 27, 2006 /PRNewswire/ -- Alimera Sciences Inc., an ophthalmic pharmaceutical company, announced today that it has completed the second tranche of its Series B financing, receiving $15.9 million in additional venture capital. This represents the culmination of the Company's Series B financing of $31.8 million secured in November 2005, at which time Alimera received an initial $15.9 million in proceeds.

The additional resources will be used to further develop Medidur(TM), Alimera Sciences' Phase III-stage treatment for diabetic macular edema (DME). The company will also use these funds to expand its development pipeline-- including additional drug delivery technologies that have been identified-- and to capitalize on other strategic opportunities as they arise.

All of the investors that committed to the Company's Series B financing in November 2005 participated in the funding of the second tranche. These investors include BA Venture Partners, Domain Associates, Intersouth Partners, Polaris Venture Partners and Venrock Associates, as well as several individual investors.

"The Alimera Sciences team is proud of the continued support we have received from our shareholders," said Dan Myers, president and chief executive officer of Alimera Sciences. "Alimera and our partners are confident in the progress we have made in the Medidur(TM) Phase III trial. We will continue to evaluate additional opportunities for our pipeline and prepare for the next stage of product development to assist the ophthalmic community in meeting the needs of its patients."

About Alimera Sciences Inc.

Alimera Sciences Inc. specializes in the development and commercialization of over-the-counter and prescription ophthalmology pharmaceuticals. Founded by an executive team with extensive development and revenue growth expertise, Alimera Sciences' products address both the anterior (front) and posterior (back) segments of the eye. In August 2004, Alimera Sciences unveiled Soothe(R), the market's first multi-dose, emollient-based artificial tear product, and in October 2005 initiated a Phase III clinical trial to study diabetic macular edema (DME) patients treated using Medidur(TM) with fluocinolone acetonide, the company's pharmacologic treatment for DME.

SPOTLIGHT: Cleveland Clinic's top 10

Thu, 09 Nov 2006 19:01:33 -0500

The Cleveland Clinic has come up with a list of the 10 best medical innovations for 2007 and a number of pharmaceutical therapies are on the list. The new cancer vaccines top the list. It's followed by designer therapeutics that use selective receptor antagonists to block side effects; ranibizumab to prevent the uncontrolled blood vessel formation at work in macular degeneration; new cancer drugs that involve cell growth inhibitors and convection-enhanced drug delivery technology that delivers drugs to a particular target. Report

VC: Esprit adds $91M, ESBATech gains $41M

Tue, 01 Aug 2006 20:01:37 -0400

Esprit Pharma has rounded up almost $91 million in its second round of venture capital. Firms participating in the Series B round included existing investors New Enterprise Associates, Apax Partners, Domain Associates and Montagu Newhall Global Partners plus new investors Oak Investment Partners and clients advised by Performance Equity Management. "While it's been just over a year since we began operations, Esprit has experienced strong growth," said John T. Spitznagel, Esprit's chairman and CEO. "In this relatively short period of time, we have applied our Buy and Build, Search and Develop strategy to acquiring four approved products, building a commercial organization including more than 200 sales and marketing professionals, and recently acquiring our first pipeline product."

- take a look at the release on the round

ALSO: Switzerland's ESBATech has raised $41 million from a consortium of U.S. and European investors in its second round of venture capital. SV Life Sciences, Clarus Ventures, HBM BioVentures and HBM BioCapital all participated with existing investors such as Novartis Venture Fund, BioMedinvest and VI Partners. The company has been building a human antibody fragment platform. Release

PLUS: Biodel, which develops drug delivery technologies, has raised $21 million in its second round. Release