Lilly Diabetes Setbacks Mount
Oct21

Lilly Diabetes Setbacks Mount

Lilly’s diabetes pipeline is taking its lumps this week, a situation that has all but quashed any notions of earnings growth in coming years. The first setback came on Tuesday, when FDA issued a complete response letter for Bydureon, a long-acting form of the diabetes treatment Byetta. Lilly and its partner Amylin won’t be able to submit a response to the CRL until late 2011, significantly pushing back the much-needed new revenue stream. Now, along with today’s third-quarter earnings report, Lilly said teplizumab, an anti-CD3 antibody, had failed Phase III trials in Type 1 diabetes. Although expectations for the treatment were modest, the latest disappointment doesn’t do much for confidence in the company’s pipeline. Further, the setbacks of Bydureon and teplizumab are not the only challenges to the company’s diabetes portfolio. Last month, in a move that was not entirely surprising, Lilly and Transition Therapeutics dropped development of TT-223, a gastrin analogue that failed to meet its goals in a small study testing the drug in combination with a Lilly GLP-1 analogue in Type 2 diabetes. Meanwhile, news this week that Pfizer was paying $200 million for Biocon’s biosimilar insulin program caused some to worry that Lilly’s generous slice of the insulin market was at risk. On a call with analysts this morning, Enrique Conterno, president of Lilly Diabetes, tried to quell investor concerns. Bangalore, India-based Biocon “basically sells when it comes to insulin about 1% of what Eli Lilly sells today,” he noted. Conterno acknowledged that Pfizer could put some heft into the Indian biotech’s commercial infrastructure, but suggested that innovation around delivery devices would differentiate players in diabetes. “Clearly this is something we will watch, but we feel very confident in our ability to be effective with our insulin portfolio,” he added. But Lilly’s pipeline woes are not limited to diabetes. In August, the company experienced a major blow when it ended development of semagacestat after the compound worsened cognition in people with Alzheimer’s disease. Semagacestat, a gamma secretase inhibitor, had been viewed as a leading contender to be the next big Alzheimer’s drug on the market. As it stands, Lilly’s profits through 2014 will be driven by what is in its pipeline and efforts to rein in costs. Last fall, the company said it would eliminate 5,500 jobs, and for those keeping track of industry-wide layoffs, today said it was only about halfway through that process and has no immediate plans to expand the cuts. The company is staring down a wave of patent expiries on key products, and with the recent pipeline setbacks, earnings growth is “moving into sharply negative territory from 2012-2015,” Bernstein Research...

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Is Pfizer After Biocon’s Insulin Portfolio?
Oct07

Is Pfizer After Biocon’s Insulin Portfolio?

The Economic Times is reporting that Pfizer is interested in buying the U.S. and European rights to Bangalore-based Biocon’s insulin franchise in a deal that would include a $200 million upfront payment. Rumors that Pfizer would buy Biocon's oral insulin product emerged in August, but the specifics on a possible pricetag have caused shares of the Indian company to rise over 8%. Biocon’s diabetes pill is in Phase III trials in India and Phase I studies in the U.S. The potential for an oral insulin product is vast, but so is the risk—getting the right balance in insulin administration is a tricky business. (Click here for my colleague Ann Thayer’s take on efforts to make inhaled or oral insulin products.) One has to wonder how much money Pfizer would be willing to pay for another alternative insulin after the colossal failure of the inhaled insulin Exubera. Low demand for the treatment prompted Pfizer to pull it from the market a year after its approval, costing the company some $5 billion after licensing fees, R&D costs, and write-offs. To be fair, an insulin pill has been the holy grail for diabetes researchers for some time. It would be less onerous than daily injections and more discrete than the unwieldy to downright ridiculous inhaled insulin instruments. Some background on Biocon’s technology: Biocon’s oral insulin program came from its 2006 acquisition of Nobex, a N.C.-based biotech that developed a way to make a pill form of biologics, which normally need to be given as an injection or IV infusion. Nobex used what it called “PegAlkylation” technology, which links a polyethylene glycol chain (those same PEGs used to improve the delivery of interferons and other large molecules) and an alkyl to a biologic like a protein or peptide. The design creates a molecule with a water-soluble and fat-soluble end that can travel through the myriad environments inside our bodies. Nobex claimed its oral insulin drug effectively reproduces the “first-phase spike,” or the large hit of insulin the pancreas puts out after a meal, a challenge for injectable and inhaled forms of insulin. Pfizer wouldn’t be the first big pharma to invest in an insulin pill. GlaxoSmithKline licensed an earlier version of Nobex’s oral insulin drug, but gave back the rights in late 2003. Nobex abandoned worked on that molecule in favor of a newer and better one, which Biocon licensed in 2004, prior to its acquisition of Nobex. Oral insulin aside, its worth noting that today’s ET story says the $200 million is for Biocon’s insulin portfolio, whereas earlier stories focused on Pfizer’s interest in the oral insulin program. European regulatory authorities recently gave the...

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Is Oral Insulin on the Horizon?
Jun02

Is Oral Insulin on the Horizon?

The Haystack wanted to point readers to a nice piece on oral delivery strategies for biotherapeutics by our colleague Ann Thayer. An injection or IV drip may be perfectly reasonable for diseases like cancer, where drugs are usually given in a hospital setting, but for chronic diseases like diabetes or multiple sclerosis, which require daily or weekly injections, a pill would be much more palatable. That said, it is awfully tough to get effective oral delivery of a big, unwieldy protein. As Thayer writes, “Acids and enzymes in the gastrointestinal tract will chew up a valuable therapeutic protein as easily as they’ll tear into a bite of steak.” Companies are especially keen to develop alternative delivery solutions for insulin. Not only would it represent a major advance for patients, but the market for a better-acting and easier-to-use insulin would be gigantic—insulin sales account for about $15 billion of the global diabetes market. Attempts at inhaled insulin have been a colossal failure. Thayer goes on to describe some of the methods biotech companies are using to enable oral delivery of insulin. Among the players: --India’s Biocon is developing IN-105, an insulin molecule conjugated to a short-chain polyethylene glycol derivative. The technology was originally developed at N.C.-based Nobex, which Biocon bought in 2006. --Ireland’s Merrion Pharmaceuticals is using technology acquired from Elan Corp. to enhance gastrointestinal permeation. In 2008, the company began working with Novo Nordisk on solid oral forms of insulin analogs; the first such analog was put into Phase I trials by Novo in late 2009. --N.J.-based Emisphere Technologies is working with Novo Nordisk on GLP-1 analogs. In January, Novo started a Phase I trial of the first candidate using Emisphere’s Eligen technology. --Isreal’s Oramed is using capsules with an enteric coating, which controls where in the intestinal tract a pill is absorbed. A Phase IIb trial of ORMD-0801 conducted in South Africa showed the drug to be safe and to have a clinical impact on insulin and gluose levels. Oramed hopes to do a Phase II study in the U.S. late this year. --Dallas-based Access Pharmaceuticals is using insulin-containing nanoparticles coated with vitamin B-12 analogs, which pull the complex into...

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