insulin

Inhaled insulin shows signs of life after setbacks

John Carroll — Tue, 16 Sep 2008 12:01:22 -0400

Mannkind took another big step toward filing an application for its inhaled insulin after releasing data from a late-stage trial demonstrating the therapy is not inferior to injected drugs that control blood sugar levels in Type 1 diabetes patients. Just as importantly, researchers noted that there was no difference in lung function measures for patients taking Mannkind's therapy, a safety factor that has dogged similar therapies.

Mannkind has stuck with its inhaled insulin program even after Pfizer, Eli Lilly and Novo Nordisk had all walked away from their own efforts in the field. In a separate announcement Pfizer said that some Exubera patients who still need an inhaled insulin will be switched to Mannkind's therapy. Investors have battered the company's stock price, but the CEO says Mannkind plans to go the distance.

"Technosphere Insulin promises to be an important additional option for the treatment of patients with Type 1 diabetes," MannKind Chief Scientific Officer Peter Richardson said in a statement. An application should follow in the next few months.

- check out the Mannkind release
- read the story from the Wall Street Journal

Cells coaxed to produce insulin in diabetes breakthrough

John Carroll — Thu, 28 Aug 2008 11:41:45 -0400

A team of scientists at the Harvard Stem Cell Institute have reprogrammed normal pancreas cells into insulin-producing cells in mice. The team injected proteins into the cells to activate genes, flipping a switch on their genetic transformation. After 10 days the cells were able to help regulate blood sugar. And the scientists say the same approach could work across a range of diseases.

"We were able to flip the cell from one state into another," Doug Melton said, adding that the approach should be useful in treating disorders in "any case where there's a cell type missing and there are neighboring cells that are still healthy."

- read the report from the Los Angeles Times

Sanofi: Acomplia demonstrates better glucose control

John Carroll — Tue, 10 Jun 2008 11:56:48 -0400

Sanofi-Aventis said that a trial of Acomplia showed a significant improvement in glucose control in comparison to insulin among patients with type 2 diabetes. Glucose control was three times more pronounced among the Acomplia group compared to volunteers who received insulin and lifestyle advice.

The drug has been approved in Europe but faces a lengthy delay in the U.S. as regulators shift through data that the drug may raise the risk of depression. In the trial, 14 percent of the Acomplia drug reported symptoms of anxiety compared to five percent in the control group and 14 percent reported symptoms of depression compared to 7.5 percent in the control arm.

- check out the AFX report

Inhaled insulin lung cancer warning riles investors

Wed, 09 Apr 2008 06:59:58 -0400

The inhaled insulin field got blitzed again today after Nektar Therapeutics and Pfizer reported an increased number of lung cancer cases among patients taking the therapy during clinical trials. Nektar swiftly dumped its effort to find a new marketing partner--Pfizer had already announced its plans to pull out--and saw its stock plunge 30 percent. Even harder hit was Mannkind, which is developing its own inhaled insulin. Its stock went into free fall, losing 60 percent of its value as investors applied some dour logic from Nektar's failure to the whole area of drug development. Looking over trial data, researchers noted that six of 4,740 patients taking Exubera developed lung cancer compared to one in the control arm. Those figures were too small to reach a statistically valid conclusion whether the drug caused the cancer, and all patients were known smokers and therefore already in a high risk category. A warning on the cancer risk will be put on Exubera labels.

The cancer warning creates yet another black eye for the prospects of inhaled insulin. Once upon a time inhaled insulin was seen as a likely garden of blockbuster therapies. But that has turned around fast, as major drug developers wash their hands of pacts and go on to other programs. Exubera was once thought to be worth more than $2 billion a year, but sales have fallen far, far short of that mark.

"Some patients continue to take Exubera, including those enrolled in extended transition programs or clinical trials. We are working closely with patients and their physicians to ensure the continued orderly transition from Exubera to alternative therapies. Physicians should seek alternate treatment options to maintain patients' glycemic control," said Joe Feczko, MD, Pfizer's chief medical officer.

- see Nektar's release
- read the report in the Wall Street Journal

Related Articles:
Pfizer gives Nektar $135M for Exubera settlement
Pfizer kills off Exubera, hunts for deals
Exubera becoming a big disappointment for Pfizer
UK: Exubera not worth the price.
MannKind bets the farm on inhaled insulin

Canadian regulators forging new biosimilar pathway

Tue, 25 Mar 2008 07:59:55 -0400

While U.S. lawmakers jawbone about a regulatory pathway for biosimilars, or biogenerics, Canada has moved to do it. Health Canada has posted draft guidelines for its regulatory approach to biosimilars. Manufacturers would have to show their products were similar to an existing biologic with interchangeability and substitutability decided on a case-by-case basis. New guidances are being drafted for various product classes.

In the U.S., meanwhile, there have been growing signs that any new legislation on biosimilars could be delayed past the current election year. But in Europe, regulators are busily approving a new slate of follow-on therapeutics.

- check out the report from FDA News
- read the article on the EMEA's approvals in Motley Fool

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Emisphere chief sees plenty of new potential for technology

Thu, 20 Mar 2008 07:59:55 -0400

When Michael Novinski took over as CEO of Emisphere Technologies, he was acutely aware of just how unsuccessful the developer had been. For 20 years, he tells the Star-Ledger, Emisphere was never able to get a single mid-stage trial right. Efforts to develop pill versions of insulin and heparin foundered as ithe company struggled. But the former president of Organon BioSciences says the company has a lot of untapped potential. A co-development deal for a pill version of Novartis' osteoarthritis and osteoporosis therapies has been struck and Novinski believes FDA approval could be only a year or two away. Novinski also believes that more such deals involving Emisphere's eli gen technology can be struck. Meanwhile, researchers for Emisphere are on the trail of a pill for diabetes.

- read the article in the Star-Ledger

Related Articles:
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Alkermes cuts staff after Lilly axes pact

Wed, 19 Mar 2008 07:59:58 -0400

Big Pharma's collective stampede from the inhaled insulin field is claiming the jobs of 150 people who work at Alkermes. The developer said it is cutting 18 percent of its staff due to Eli Lilly's decision to follow the example set by Novo Nordisk and Pfizer and pull out of their insulin development program. Alkermes is also closing a manufacturing facility in Chelsea, MA.

"We are implementing a new operational cost structure to align our expenses with near-term revenues, which we anticipate will be lower than expected due to Lilly's termination of the inhaled insulin program," Cambridge, MA-based Alkermes said.

- here's the release
- read the report from Thomson Financial

Related Articles:
Alkermes: Lilly may dump inhaled insulin program. Report
Lilly touts inhaled insulin. Report
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Alkermes inks rich collaboration deal for Vivitrex. Report

Follow-on legislation follows a twisted path in DC

Mon, 17 Mar 2008 07:59:57 -0400

BIO is toasting proposed new legislation that would provide more than 14 years of patent protection on a biologic. Needless to say, the generics crowd is just a tad disappointed by the bill, saying that patients would have to wait decades before they could benefit from any lower prices. "For the countless patients who are choosing between paying for their medicines and putting food on their tables, waiting decades is simply not an option," said the Generic Pharmaceutical Association. BIO feels a lengthy period of patent protection is the only fair option, given the time it takes to move a biologic to regulatory approval.

As the Wall Street Journal's blogsters point out, new legislation providing a regulatory pathway for biologics gets a thumb's up from most everyone--but no one agrees just how lawmakers should do it. One other commonly agreed point: Starting out, the FDA is likely to take it one biologic at a time, deciding when and how for each program.

- read the Generic Pharmaceutical Association statement
- read the report from the Wall Street Journal

Related Articles:
Waiting game continues for biogenerics. Report
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Axial Biotech snares $6M tranche of venture funding

Mon, 17 Mar 2008 07:59:54 -0400

Johnson & Johnson Development Corporation along with vSpring Capital and Ohio Biotech Group have stepped in to provide a $6 million tranche for Axial Biotech's second round of venture capital. Axial is advancing new technology in molecular diagnostics and motion preserving to develop a genetic prognostic test for Adolescent Idiopathic Scoliosis. Axial says it has met several scientific milestones in its work on the test.

- see this release for more

ALSO: EnGene, which is developing a treatment for diabetes called GEMS-Insulin, announced today it has raised $6.4 million in a Series A financing. Release

Insulin retreats blamed for Generex stock drop

Tue, 11 Mar 2008 07:59:58 -0400

Generex is firmly in the camp that sees the glass as half full. After seeing its share price slide 16 percent yesterday, the developer attributed the sudden setback to decisions by Eli Lilly, Pfizer and Novo Nordisk to pull out of programs to develop other inhaled insulin products.

Worried? No, says Generex, happy to extol its late-stage drug's safety profile. The company says its Oral-lyn insulin doesn't leave a deposit in the lungs. And there's reason for cheer; the departure of the big companies removes some heavyweight competitors, says Generex.

Generex's stock woes followed a recent announcement from Alkermes that Eli Lilly is dropping out of their collaboration on an inhaled insulin therapy. Novo Nordisk and Pfizer have already pulled out of their respective programs. MannKind, meanwhile, reiterated its plans to forge ahead in the field.

- see the statement from Generex
- read the MarketWatch report

Related Articles:
Analyst gives bullish assessment of Generex program. Report
Generex initiates Phase II Trial in breast cancer patients. Report
MannKind bets the farm on inhaled insulin. Report
Pfizer kills off Exubera, hunts for deals. Report
Novo Nordisk shelves inhaled insulin, axes staffers. Report

Alkermes: Lilly may dump inhaled insulin program

Fri, 07 Mar 2008 06:59:55 -0500

Alkermes says it wants to push ahead with a broad late-stage study of its inhaled insulin program, even though it believes that Eli Lilly is preparing to pull out of their collaboration deal. Alkermes issued a statement saying that Eli Lilly "is evaluating its business case for AIR Insulin and Alkermes expects Lilly to make a decision to discontinue the program in the next week. Alkermes is not aware of any safety, efficacy, or manufacturing issues that have arisen regarding AIR Insulin since Lilly's last public update on the program."

Lilly has recruited thousands of patients for a number of trials of the inhales insulin, according to Alkermes, harvesting encouraging safety and efficacy data along the way. Alkermes say its seeking an update from Lilly on the status of the trials.

- check out the press release from Alkermes

Related Articles:
Lilly touts inhaled insulin. Report
Alkermes provides pharmocokinetic data. Report
Alkermes inks rich collaboration deal for Vivitrex. Report

Novocell reports breakthrough in diabetes cure

Thu, 21 Feb 2008 06:59:57 -0500

Researchers at Novocell report a key breakthrough in their program to find a cure for diabetes. The company reports that the researchers were able to turn embryonic stem cells into insulin-producing cells in mice. And after the mice's insulin-producing cells had been destroyed, the new cells kept their blood sugar levels in check.

"For those who say there is not much evidence that embryonic stem cells can cure diabetes, there you go," Dr. Camillo Ricordi, director of the Diabetes Research Institute at the University of Miami told The New York Times. Dr. Ricordi was not involved in the research program. The research did raise red flags, though. Some of the mice in the study developed tumors and there were questions raised whether the cells were characterized well enough for use in humans. Human trials are still several years away.

- read the article in The New York Times

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BioCon buys stake in German pharma company

Fri, 15 Feb 2008 06:59:56 -0500

Fulfilling an earlier promise to acquire a company, Bangalor-based BioCon has spent €30 million to purchased a 70 percent stake in German pharmaceutical company AxiCorp. The deal will allow BioCon to market its injectable insulin, Insugen, in Europe; it will be followed by other generics, biosimilars and biologics.

In January BioCon indicated that it was exploring ways to promote its products in North America and Europe, and planning to spin off its clinical research group. According to Biocon's release, this marks the first of several acquisitions Biocon has planned following the sale of its enzymes business last year. "We are very focused on becoming a key player in insulin globally," said a BioCon spokesperson. "We can deliver through a combination of Biocon's low cost manufacturing and AxiCorp's low cost distribution."

- here's the release
- and check out this Economic Times report

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Pfizer focuses on expanding inhaled meds R&D

Wed, 13 Feb 2008 06:59:57 -0500

Pfizer is budgeting €130 million for the construction of a new facility in France to specialize in the development of inhaled meds. Plans for the facility in Amboise include a staff of 440, more than making up for the loss of 110 jobs in the town when Pfizer closes a separate R&D operation. Work on the new facility begins this year and should take about five years.

As In-Pharma reports, the move by Pfizer shows that it still believes in the future of inhaled medications, even after the troubles it had with the Exubera fiasco, for which it incurred a charge of $2.8 billion.

- read the AFX report
- and here's the article from in-Pharma

ALSO: Nektar, meanwhile, is cutting more than 100 staffers and eliminating 40 open positions as it restructures in the wake of Pfizer's withdrawal as a partner on Exubera. COO Dr. Hoyoung Huh is leaving Nektar to become CEO of BiPay Sciences in Australia. Report

Related Articles:
Pfizer pays $135M to ease Exubera pain. Report
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Exubera becoming a big disappointment for Pfizer. Report
UK: Exubera not worth the price. Report
FDA approves Pfizer's inhaled insulin. Report

Novo Nordisk shelves inhaled insulin, axes staffers

Tue, 15 Jan 2008 06:59:58 -0500

There's another big loser in the inhaled insulin game. Shares of Novo Nordisk were trimmed more than four percent after the Danish developer announced it was dropping its short-acting AERx insulin inhaler after coming to the conclusion that it had little commercial value and was no better than injectable insulin. The AERx inhaler was in late-stage trials.

Company officials said they would trim hundreds of jobs and write off $260 million as a result of the move. Pfizer dropped Exubera last fall after the inhaled diabetes product failed to live up to, or even get close to, a much heralded blockbuster status. Novo says it will continue to develop other experimental inhaled diabetes therapies. That's not likely to be any consolation to Novo's workers at its Hayward, CA facility, where about 300 employees face the axe.

- see Novo's release
- read the report from Dow Jones

Related Articles:
Mixed data for Novo's diabetes drug. Report
Pfizer kills off Exubera, hunts for deals. Report
MannKind bets the farm on inhaled insulin. Report
Exubera becoming a big disappointment for Pfizer. Report

ALSO NOTED: Savient shares soar on trial results; Pharming handed a rejection on Rhucin;ARCH closes $400M VC fund; and much mor

Thu, 13 Dec 2007 06:59:50 -0500

> It wasn't all bad news on Wall Street. Shares of Savient jumped almost 50 percent after researchers announced that its experimental gout therapy, Puricase, met the main goal of a late-stage trial. Report

> Pharming says that the CHMP in Europe has rejected its marketing application for Rhucin. The company says it will appeal. Release

> With Congressional committee breathing down its neck for the latest trial data on the cholesterol drug Vytorin, shares of Schering-Plough slid about 3.7 percent. Lawmakers want the data, but researchers in the project say they've delayed it due to the complexity of the information. Report

> Chutes & Ladders: Fundamental Applied Biology has raised $21 million in its second round and named former HGS VP Daniel Gold as its new chief executive. Report

> Just months after Pfizer stopped selling its inhaled insulin product, West Pharmaceuticals announced that it will slash 250 jobs in its Tech Group. Release

> Arch Venture Partners, a big player in the biotech arena, has closed its latest fund with $400 million to invest. Arch specializes in backing startups that rely heavily on new scientific research and entrepreneurial management. "We have a firm belief that investing in fundamental biotechnology innovations is one of the few areas that wins in cyclical economies." said Robert Nelsen, Managing Director. "We have seen our biotech platform companies do quite well throughout repetitive cycles, contrary to the industry trend toward 'product-only' companies. Our focus is on the most innovative opportunities, from pioneering technology to landmark products to expanding into unconventional markets." Release

> Lonza and BioWa will collaborate on creating an optimized production platform for more potent antibodies. Report

> The FDA has issued a new warning on carbamazepine, an epilepsy-slash-bipolar drug that can cause rare but severe side effects in certain patients of Asian descent. Report

> Surprise! You're the next CEO. So said Shire to CFO Angus Russell (photo), who got an unexpected promotion to the company's top slot. Report

> Scrub the gilt edge off those bonds. Fitch Ratings ripped the AAA rating off Pfizer's debt, citing the drug maker's "maturing" drug portfolio and its thinly populated pipeline. Report

And Finally… With 20 high-cost procedures leading the way, the nation's hospital bill jumped 7 percent in 2005, twice the rate of inflation. Report

MannKind bets the farm on inhaled insulin

Fri, 16 Nov 2007 06:59:56 -0500

Pfizer's huge investment in the inhaled insulin drug Exubera turned into a major disappointment when the drug did only $12 million in sales, causing Pfizer to promptly abandon the drug. But despite that monumental flop, billionaire Alfred E. Mann (photo), CEO and controlling shareholder of California-based MannKind, is confident that his company's inhaled insulin product has what it takes to revolutionize diabetes treatment--and he's putting up is own money to prove it.

Mann says that Technosphere is more effective and faster acting than currently available therapies. The device used to deliver the drug (photo) is much smaller than the Exubera inhaler (photo), which many people found to be bulky and inconvenient. The drug is also faster-acting than any other insulin on the market, and may reduce the risk of low blood glucose levels in diabetic patients.

Skeptics say Mann has an uphill battle ahead of him. Potential competitors in the inhaled insulin space include Eli Lilly and Novo Nordisk, which are both conducting late-stage trials for their drugs. There is concern that Technosphere is too short-acting. Additionally, in trials, more patients on Technosphere chose to discontinue treatment--the reasons why are unclear. But Mann has unshakable faith in the drug and is betting a whole lot of money that he's right. "I believe this is one of the most valuable products in history in the drug industry, and I'm willing to back it up with my estate," he told The New York Times.

- read this NYT article for more

Related Articles:
Pfizer kills off Exubera, hunts for deals. Report
MannKind searches for insulin drug partner. Report
MannKind garners $175M for inhaled diabetes therapy. Report
MannKind reports Q3 results. Report

Pfizer gives Nektar $135M for Exubera settlement

Tue, 13 Nov 2007 06:59:55 -0500

Nektar Therapeutics got a consolation prize of $135 million from Pfizer--and a fresh shot at signing a new partner--to calm any upset feelings about Pfizer's abandonment of Exubera, a once mighty prospect in the world of inhalable diabetes therapies. In return, both parties are absolved of any further obligations for Exubera or the next-generation version of the therapy that Nektar has in Phase I. And if Nektar lines up a new partner, Pfizer has agreed to hand over any rights it has in the two products.

- check out Pfizer's release
- here's the report on Nektar from RTT News

Related Articles:
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Exubera becoming a big disappointment for Pfizer. Report
UK: Exubera not worth the price. Report
FDA approves Pfizer's inhaled insulin. Report

FDA approves Anesiva's needle-free pain drug

Fri, 17 Aug 2007 06:59:58 -0400

The FDA has given Anesiva a nod for Zingo, a single-use, needle-free system containing sterile lidocaine powder. Zingo provides rapid relief for pain associated with venous access procedures, such as intravenous insertions or the drawing of blood for tests. "Blood draws and IV insertions are the most frequently reported painful events in hospitalized children. Despite guidelines recommending the use of topical anesthetics prior to venous access procedures, currently available local anesthetics commonly take 20 minutes or longer to act, making their use in today's fast-paced hospital environment difficult. FDA approval of Zingo provides a unique option for healthcare providers who strive to safely and effectively manage children's pain during these procedures," said John P. McLaughlin, CEO of Anesiva.

Anesiva says that its needle-free delivery system may have broader applications, such as administration of insulin, human growth hormone, erythropoietin, calcitonin and other medications, excluding vaccines. Anesiva says it is open to licensing deals for the needle-free tech.

- see this release for more

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Insulin debate spurs push for generic biologics

Wed, 10 Jan 2007 19:01:36 -0500

The heat is on the FDA to find a way to approve a generic insulin, the oldest existing biologic on the market. And some observers say that the push is likely to spur a broader effort for a generic regulatory pathway for all biologics. Insulin has been used in form or another since the 1920s, but there has never been a generic form approved. Some $3.3 billion dollars a year is spent on insulin.

- read the report from FierceHealthcare
- here's the article from The New York Times

ALSO: Eli Lilly has decided to stop construction of a new insulin manufacturing plant in Virginia. Another 250 U.S. plant workers are losing their job as Lilly expands a biotech manufacturing facility in Ireland. Release

Related Article:
Insulin delivered in tiny carbohydrate shells. Report