Shire

Shire to buy Jerini in $521M deal

John Carroll — Thu, 03 Jul 2008 09:42:20 -0400

With an eye toward snapping up a late-stage orphan drug for hereditary angiodema--a rare genetic disease--Shire has agreed to pay $521 million to acquire Berlin-based Jerini. That's a whopping 73 percent premium on Jerini's share price at Wednesday's close. Shire made it clear that it wants to add Firazyr to its portfolio. The therapy is expected to gain European approval later this year.

Jerini's other assets will undergo a "strategic review" following completion of the sale. Those other assets that may go on the sales block include Jerini Ophthalmic, a U.S. subsidiary working on wet age-related macular degeneration, and JPT Peptide Technologies GmbH, a manufacturing operation.

Annual sales of Firazyr are estimated at $350 million to $400 million a year. But Jerini has run into trouble with the FDA, which issued a non-approvable letter on the therapy. Shire, though, says it is confident that the agency's questions have been addressed.

"The proposed acquisition of Jerini would bring to Shire a new drug that is highly complementary to our HGT portfolio," says Shire CEO Angus Russell (photo). "Consistent with our strategy, Firazyr is a product which satisfies a high unmet medical need and treats a morbidly symptomatic disorder. With orphan designation in both Europe and the U.S., and a launch in Europe in the second half of this year, the acquisition will bring near term revenues as well as contribute to Shire's longer-term growth."

- see the release
- check out the AFX report
- and read the AP story

Mixed data for Renovo's scarring therapy

Mon, 03 Mar 2008 06:59:57 -0500

Renovo's Juvista produced a mixed set of data in two mid-stage trials. The drug produced positive data in reducing scarring but failed to demonstrate efficacy during a breast augmentation trial. Researchers also said that the therapy was more effective against scarring when administered twice and noted that during the breast augmentation trial the drug was administered once. Renovo plans to launch a Phase III trial of Juvista in the second half of this year. Shire, a partner on the drug, agreed to invest $75 million in Juvista, plus make a $50 million equity investment in Renovo.

"Shire is at present assessing these latest results with all other results produced to date and plans to discuss these with the FDA in 2008 to determine the regulatory path forward in the United States," said Renovo in a statement.

- read the press release for more information

Related Articles:
Renovo inks $875M deal for scarring drug. Report
Renovo CEO bullish on partnership prospects. Report
Renovo sees shares jump on first day. Report

Shire, Amicus forge $440M pact

Thu, 08 Nov 2007 06:59:55 -0500

Amicus Therapeutics has scored a $50 million upfront payment from Shire's human genetics sub for rights outside the U.S. to three experimental therapies for genetic disorders: Amigal (migalastat hydrochloride) for Fabry disease (Phase II), Plicera (isofagomine tartrate) for Gaucher disease (Phase II) and AT2220 (deoxynojirimycin) for Pompe disease (Phase I). Amicus stands to gain $150 million for development milestones and $240 million in sales milestones plus royalties. Both companies will share expenses in the development pact. For Shire, the deal marks another expansion of its pipeline of new therapies for genetic disorders. Two years ago it paid $1.6 billion for Transkaryotic Therapies. One of the leaders in the field of new treatments for genetics disorders is Genzyme, which has been aggressively beefing up its own pipeline.

- check out the release for more info

Related Articles:
Shire on lookout for acquisitions. Report
Shire to Massachusetts: Pass incentive bill now. Report

ALSO NOTED: Big CEO turnover at Big Pharma; New company takes on RNAi field; Shire hunts for buyouts; and much more...

Fri, 02 Nov 2007 07:59:50 -0400

> Turnover at the top of Big Pharma has been running at an unprecedented pace. And now, with fresh faces at the helm at nine of the world's top 12 pharma companies, there's a new generation running things. Report

> According to The In Vivo Blog, a new company is taking on the hot field of RNAi. Dicerna Pharmaceuticals is expected to announce a $13 million first round of funding led by Oxford Biosciences. Post

> Fresh off its best quarterly results ever, Shire says it's still in the market for smaller companies to buy. Report

And Finally... Case Western Reserve University researchers have bred a line of "mighty mice" that can run five to six kilometers at a speed of 20 meters per minute on a treadmill for up to six hours before stopping. Report

3. Shire and Renovo

Maureen Martino — Tue, 11 Sep 2007 09:00:30 -0400

Who: Shire
With: Renovo
What: $875 million

Summary: Shire forked over $75 million up front along with a $50 million equity payment to Renovo as part of an $875 million deal for the exclusive development and commercialization rights to Juvista, a scarring drug. The deal includes $700 million in scheduled milestone payments. The drug is intended for use after surgery and cosmetic procedures as well as for burn victims. If it survives the approval process, analysts speculate that Justiva garner a whopping $4 billion a year in the U.S. market alone. The therapy is in development and could be approved in 2011. The partnership covers countries outside of the EU. Release

Related Articles:
Shire, Renovo ink $875M deal for scarring drug. Report
Renovo CEO bullish on partnership prospects. Report

Shire to Massachusetts: Pass incentive bill now

Fri, 31 Aug 2007 06:59:58 -0400

The Massachusetts Legislature is taking its sweet time passing Governor Deval Patrick's proposed $1 billion incentive bill, and Shire is not too happy about it. The U.K.-based drug company was planning to build a $210 million plant in the state, but Shire is now threatening to take its business (and the 600 jobs it would create) elsewhere unless the state government passes the incentive package. North Carolina in particular is angling to attract Shire's business.

Back in July, Massachusetts Governor Patrick (D) filed a 10-year, $1 billion biotech investment bill designed to help the state keep its lead in the industry. The proposal included $25 million in tax incentives to attract pharmaceutical and biotech companies to Massachusetts. However, the bill is currently cooling its heels in the state's House of Representatives, which has yet to start the review process. "The process has been somewhat slower than what we originally anticipated," said a Shire spokesperson. The life science economic development world is cutthroat, and Massachusetts can't afford to drag its feet.

- see this article

Related Articles:
Mass. announces $1B stem cell plan. Report
Mass. fills in the details on $1B biotech program. Report
Top five regions targeting biotech companies--2007. Report
Boston biotech booming as scientific research flourishes. Report

ALSO NOTED: Avandia gets Black Box Warning; Shire licensing deal complete; Pittsburgh companies gain financing; and much more..

Wed, 15 Aug 2007 06:59:50 -0400

> Hang the black crepe: the FDA has ordered new "black box" warning labels for Avandia and its Japanese cousin Actos. FiercePharma

> Schering-Plough has suspended development of a clinical compound for metabolic disease. Report

> Shire's licensing deal for Justiva has become effective. Report

> Pittsburgh Life Sciences Greenhouse has invested $350,000 in three local life sciences companies. Release

> EKR Therapeutics has acquired exclusive marketing and distribution rights to DepoDur (morphine sulfate extended release liposome injection) for the Americas from San Diego-based Pacira Pharmaceuticals. Release

> Caraco Pharmaceutical Laboratories announced a big expansion of its Detroit facilities, creating 600 jobs over the next five years. FiercePharma

> China's pharma market steams ahead. FiercePharma

> In a breakthrough, team of scientists at Oregon Health & Science University's school of medicine has engineered mice that produce human liver cells. FierceBioresearcher

And Finally... Should terminally ill patients be given access to unapproved drugs that have completed only Phase I studies? Poll

Noven garners $25M payday on sales milestone

Tue, 31 Jul 2007 06:59:55 -0400

Noven will pocket the second of three potential $25 million milestones outlined in its deal with Shire. Shire says that the ADHD drug Daytrana continues to rack up enough market share to trigger the payments, exceeding $50 million in revenue for the 12 months ended on June 30. Noven will get its third big milestone payment if Daytrana breaks the $75 million mark.

- check out the release
- here's the report from Tech Journal South

Related Articles:
Noven expands pipeline with $125M JDS buyout. Report
FDA rejects Noven's copycat version of Duragesic pain patch. Report
FDA approves Daytrana ADHD patch. Report

ALSO NOTED: CRO market hits $14B; Merck ends BioXell pact; and much more...

Fri, 20 Jul 2007 06:59:50 -0400

> Merck has ended its collaboration with BioXell on its sepsis drug TREM-1. BioXell says it will seek another company with which to partner on the drug. Report

> Shire is expanding its U.S. operations, adding 360 jobs in Pennsylvania. Release

> According to a new report, pressure to reduce costs and time-to-market has lead to a rapid growth in the CRO market, which was valued at $14 billion in 2006 and is predicted to balloon to $24 billion by 2010. Release

> Galapagos has gained a milestone payment in its collaboration with Boehringer Ingelheim. Release

And Finally... The biotech and technology industries are at odds over a new bill designed to revamp the patent process. Article

Progeria trial underscores challenge of rare diseases

Mon, 29 Jan 2007 19:01:36 -0500

The mother of a young boy with Progeria has paved the way to the world's first clinical trial into a potential treatment of the disease, which will require recruiting more than half of the 42 known patients in the world. The case underscores both the promise of new genetic research into potential treatments as well as the challenges researchers face in studying rare diseases. Progeria affects only one in every four million to eight million children, most of whom die from a stroke or heart attack by the age of 13.

- here's the article from The Wall Street Journal (sub. req.)

Related Articles:
FDA approves Shire's Elaprase for rare disorder. Report
NIH budgets $71M to study rare diseases. Report
FDA approves Novartis' Gleevec for five rare diseases. Report

SPOTLIGHT: Avexa gains rights to HIV drug

Mon, 22 Jan 2007 19:01:33 -0500

Shire has licensed the North American rights to the HIV compound SPD754 to Australia's Avexa in exchange for an up front payment of $10 million and sales and development milestones. Shire gets eight million shares of Avexa in the deal, boosting its stake in the company to eight percent. Release | Report

Press Release: FDA Approves Shire's Lialda

Maureen Martino — Wed, 17 Jan 2007 10:01:50 -0500

FDA Approves LIALDA(TM) (mesalamine), the First Oral Once-Daily Mesalamine for Patients With Active, Mild to Moderate Ulcerative Colitis

BASINGSTOKE, England, and PHILADELPHIA, Jan. 16 -- Shire plc announced today that the U.S. Food and Drug Administration (FDA) has approved LIALDA(TM) (mesalamine) with MMX® technology, indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. LIALDA is the first and only FDA-approved once-daily oral formulation of mesalamine. Mesalamines are a part of a drug class called aminosalicylates, which contain 5-aminosalicyclic acid (5-ASA), a well-established drug of choice and often a first-line treatment for patients with mild to moderate ulcerative colitis. Shire will launch LIALDA in the U.S. in the first quarter of 2007.

Once-daily LIALDA with MMX technology contains the highest mesalamine dose per tablet (1.2 g), so patients can take as few as two tablets once daily. Other currently available mesalamines require three to four times daily dosing and 6 to 16 pills a day. A recent study conducted by the Crohn's and Colitis Foundation of America (CCFA) found that 65 percent of patients with ulcerative colitis are poorly compliant with their medication, citing pill burden and inconvenience associated with the medication.

"As the first oral once-a-day treatment option for ulcerative colitis, the approval of LIALDA in the United States is great news for patients and physicians when managing this serious condition," said Matthew Emmens, Shire Chief Executive Officer. "Once-daily LIALDA is one of several medicines Shire expects to launch in the U.S. and Europe in 2007."

The FDA approval was based on the results of two Phase III clinical studies that found LIALDA (2.4 g/day and 4.8 g/day) was effective in inducing remission in patients with active, mild to moderate ulcerative colitis compared to placebo after eight weeks of treatment. LIALDA is generally well tolerated and has a similar safety profile to other currently available mesalamines.

"In clinical trials, LIALDA proved to be an effective medication, providing superior rates of remission compared to placebo for people with ulcerative colitis," said lead study investigator, Gary R. Lichtenstein, M.D., director of the Center for Inflammatory Bowel Diseases at the Hospital of the University of Pennsylvania. "This is the first new mesalamine treatment to enter the market since 2000, filling a major void for physicians and people with ulcerative colitis and simplifying treatment of this disease."

"The introduction of new treatments with more convenient dosing regimens may be an important step in helping patients with ulcerative colitis remain compliant with their medication," said Jonathan Braun, M.D., Ph.D., chair of CCFA's National Scientific Advisory Committee.

Shire has licensed from Giuliani S.p.A. the exclusive rights to develop and commercialize LIALDA in the U.S., Canada, Europe -- known as MEZAVANT(TM) -- (excluding Italy) and the Pacific Rim. Giuliani S.p.A. retains the development and commercialization rights in Italy. Cosmo Pharmaceuticals S.p.A., Milan developed the MMX technology and owns the trademark, MMX.

For more information on LIALDA, please visit http://www.LIALDA.com .

Important Safety Information

LIALDA tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. Safety and effectiveness of LIALDA beyond eight weeks has not been established.

LIALDA is generally well tolerated. The majority of adverse events in the double blind, placebo-controlled trials were mild or moderate in severity. In clinical trials (N=535), the most common treatment related adverse events with LIALDA 2.4 g/day and 4.8 g/day were headache (5.6 percent and 3.4 percent, respectively) and flatulence (4 percent and 2.8 percent, respectively). LIALDA is contraindicated in patients with hypersensitivity to salicylates (including mesalamine) or to any of the components of LIALDA. Caution should be used in patients with impaired hepatic or renal function.

MMX Technology

LIALDA is the only ulcerative colitis treatment that utilizes novel MMX technology. LIALDA with MMX technology combines a pH dependant gastro- resistant coating, which delays the release of the medication to the colon (the site of the inflammation in ulcerative colitis) with a tablet core containing mesalamine with hydrophilic and lipophilic excipients.

Clinical Studies

The approval of LIALDA was based on the results of two Phase III clinical studies. The first study assessed the efficacy and safety of LIALDA 2.4 g/day given in divided doses twice daily and 4.8 g/day given once daily against placebo in 262 patients. At eight weeks, both doses demonstrated superiority over placebo in the induction of remission (34.1 percent with 2.4 g/day, 29.2 percent with 4.8 g/day, and 12.9 percent with placebo). The second study assessed the efficacy and safety of LIALDA 2.4g/day and 4.8g/day (both given once daily) against placebo in 255 patients. At eight weeks, both once daily doses demonstrated superiority over placebo in the induction of remission (40.5 percent with 2.4 g/day, 41.2 percent with 4.8 g/day, and 22.1 percent with placebo).

About Ulcerative Colitis

Ulcerative colitis is a type of inflammatory bowel disease that produces inflammation and sores or ulcers along the inside of the large intestine, also called the bowel or colon. The sores interfere with the normal digestive process, often causing cramping, bloating, diarrhea, bleeding, fatigue, weight loss and frequent bowel movements. This serious, chronic autoimmune disease affects approximately 500,000 Americans. For an informative white paper on ulcerative colitis, visit http://www.managinguc.com .

Shire's strategic goal is to become the leading specialty pharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit and hyperactivity disorder (ADHD), human genetic therapies (HGT), gastrointestinal (GI) and renal diseases. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. Shire believes that a carefully selected portfolio of products with a strategically aligned and relatively small-scale sales force will deliver strong results.

Shire's focused strategy is to develop and market products for specialty physicians. Shire's in-licensing, merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe.

For further information on Shire, please visit the Company's website: http://www.shire.com .

Guiliani S.p.A.

Giuliani S.p.A., founded in 1889, is a privately owned specialty pharmaceutical company with Headquarters in Milan, Italy. It develops new products with high unmet medical need and substantial market opportunity. It is focused on developing and marketing products for the treatment and management of gastrointestinal (ulcerative colitis and Crohn's disease), metabolic (food intolerance) and dermatological (hair loss) disorders.

Cosmo S.p.A.

The formulation for LIALDA was developed by Cosmo S.p.A. Cosmo also owns the drug delivery and process patents covering this compound. Cosmo S.p.A. is an R&D pharmaceutical company. Its R&D covers advanced drug delivery with applications in gastrointestinal disorders, new chemical entities and biotechnology. In addition, it manufactures pharmaceuticals and offers development services to other pharmaceutical companies. Cosmo is based in Lainate (Milan), Italy, where its production plant and principal R&D laboratories are situated. Its biotechnology R&D is located in La Jolla, California, USA.

"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

Statements included herein that are not historical facts are forward- looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire's results could be materially affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of pharmaceutical research, product development, manufacturing and commercialization; the impact of competitive products, including, but not limited to the impact of those on Shire's Attention Deficit and Hyperactivity Disorder (ADHD) franchise; patents, including but not limited to, legal challenges relating to Shire's ADHD franchise; government regulation and approval, including but not limited to the expected product approval dates of SPD503 (guanfacine extended release) (ADHD), SPD465 (extended release triple-bead mixed amphetamine salts) (ADHD), MEZAVANT(TM) (SPD476) (mesalazine) in Europe, and VYVANSE(TM) (NRP104) (lisdexamfetamine dimesylate) (ADHD), including its scheduling classification by the Drug Enforcement Administration in the United States; Shire's ability to secure new products for commercialization and/or development; and other risks and uncertainties detailed from time to time in Shire's and its predecessor registrant Shire Pharmaceuticals Group plc's filings with the Securities and Exchange Commission, particularly Shire plc's Annual Report on Form 10-K for the year ended December 31, 2005.

FDA approves Shire's new ulcerative colitis drug

Tue, 16 Jan 2007 19:01:36 -0500

The FDA helped nudge up shares of Shire this morning with the announcement that the agency had approved its ulcerative colitis drug Lialda. In trials Lialda demonstrated its ability to reduce the remission of mild to moderate ulcerative colitis after eight weeks of therapy. The drug will be released in the first quarter of this year.

- read the report on Shire from TheStreet.com

Related Articles:
FDA approves Shire's pricey Elaprase. Report
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ALSO NOTED: Shire drug gets second approvable letter; Galapagos acquires ProStrakan sub; FDA asks Allergan for more data; and m

Thu, 21 Dec 2006 19:01:30 -0500

> The FDA has issued its second approvable letter for Shire's ADHD drug Vyvanse. Report

> Galapagos has acquired ProSkelia, a French subsidiary of ProStrakan in a deal worth up to €45 million. Report

> Allergan has announced that the FDA has asked for more data on its eye pressure medication Combigan. Report

> The FDA has approved Novartis' Exforge for high blood pressure. Release

> Protiva Biotherapeutics has filed an appeal that seeks to overturn the BC Supreme Court's ruling that would permit Inex Pharmaceuticals Corporation to transfer the Inex-Protiva agreements to Tekmira Corporation without Protiva's consent. Release

And Finally... Drug reps will face a tough year in 2007. Report

Shire, New River shares surge on FDA approval

Sun, 08 Oct 2006 20:01:37 -0400

Shares of Shire and New River Pharmaceuticals were on the rise this morning as investors responded to the news that the FDA had approved NRP104, its next generation version of the popular ADHD drug Adderall. New River shares soared 51 percent in early trading as investors considered the impact of a milestone payment of up to $300 million and $100 million in annual bonuses if the drug breaks the billion-dollar revenue mark. Analysts were particularly bullish about the FDA's signal that no new studies would be needed to clear a market launch. Discussions about labeling requirements are in the works, but there's nothing in the approval that would indicate the developers can't make or beat their goal to launch NRP104 in the second quarter of next year.

- read the article on the approval from MarketWatch

PLUS: The FDA has approved Sepracor's Brovana for COPD. Report

ALSO: The FDA has approved Merck's Zolinza for non-Hodgkin's lymphoma in patients who have failed other therapies. Report

AND: The agency has approved J&J's Risperdal as a therapy for irritability in autistic children and adolescents. Report

FDA approves Shire's pricey Elaprase

Mon, 24 Jul 2006 20:01:39 -0400

Shire has received FDA approval for the first therapy designated for Hunter syndrome, a rare disorder that is linked to potentially fatal growth problems in children. Only about 500 people in the U.S. are afflicted by Hunter syndrome and about 100 of them have been involved in the clinical testing of Elaprase. Shire says it expects to market the drug for a cost of $300,000 a year, making it one of the most expensive medications on the market. Elaprase is an enzyme replacement therapy which injects a critically needed protein into the patient's bloodstream. These therapies are frequently targeted at tiny patient groups and are priced to bring in a significant amount of cash.

- read the article on Elaprase from The Boston Globe

FDA delays decision on Shire's Elaprase

Tue, 16 May 2006 20:01:35 -0400

The FDA will delay its decision on Shire's experimental drug Elaprase for Hunter's syndrome so that it can consider additional data. A decision is now expected by August 24, which Shire says will allow it to start marketing the drug in the latter part of this year. Hunter's syndrome is a rare genetic disorder that afflicts about 2,000 people worldwide.

- read the AP's report on Elaprase

ALSO NOTED: FDA delays Adderall decision;Actavis raises Pliva bid; and much more...

Thu, 20 Apr 2006 20:00:50 -0400

> Shire says that the FDA has told the company that it hasn't been able to make a decision on its concerns that copycat versions of Adderall XR are too easy to produce. Shire wants the agency to require more rigorous bioequivalence testing. Report

> Iceland's Actavis has raised its bid for Pliva by 11 percent. Report

> Omrix Biopharmaceuticals has priced its IPO at $10 a share. Report

> NovaDel has raised $12 million from a stock sale to fund new clinical development work. Release

> Akorn and India's Natco have inked a deal to commercial two injectable therapies. Release

> An updated safety review by Nymox of NX-1207 for benign prostatic hyperplasia has revealed no serious side effects. Report

> GTx is launching a Phase IIIb trial of Acapodene in men undergoing androgen deprivation therapy for prostate cancer. Report

> The FDA has yet to complete a review of Advancis' marketing approval request for additional Keflex products. Keflex is a popular antibiotic. Release

And Finally… Researchers have found a genetic link for the hard-to-diagnose chronic fatigue syndrome. Article

FDA approves Daytrana ADHD patch

Thu, 06 Apr 2006 20:01:38 -0400

The FDA has approved Daytrana, the first patch for treating ADHD. The therapy was developed by Noven Pharmaceuticals and Shire, which has the global marketing license. The companies said the new treatment would be released in mid-2006. It's designed to be worn by children throughout the day, who will receive a steady dose of the therapy. That is intended to help young patients who would have trouble staying up with oral formulas. Noven received an up-front payment of $25 million and stands to gain up to $125 million in milestones.

- here's a MarketWatch report on the patch

Shire says Daytrana action is looming

Thu, 09 Mar 2006 19:01:36 -0500

The FDA's decision to treat Shire's resubmission of Daytrana--a transdermal patch for attention deficit hyperactivity disorder for children 6 to 12--has led the company to conclude that it should get the agency's decision on the therapy early next month. The FDA had issued an approvable letter for Daytrana in December, asking for more information. If they get the FDA's approval, Shire expects to launch the treatment in the first half of this year.

- here's the AFX report