LONDON, June 18, (RTRS): A promising new diabetes drug being developed by Roche, under license from France’s Ipsen, faces a delay of at least 12 to 18 months after hypersensitivity problems were seen in some patients.
The higher rate of reactions in patients taking the drug triggered a change in clinical trial protocols, causing the delay to the development programme and raising questions about the medicine’s commercial potential.
Industry analysts at Jefferies said the market might now fully discount the drug because of worries about its future.
Swiss-based Roche said on Friday it was implementing a risk mitigation plan in the taspoglutide Phase III programme following cases of hypersensitivity reactions to the medicine, which is an injected product belonging to the GLP-1 class.
“The impact of this plan on the project and in particular on the timelines for regulatory filing are currently being assessed, however, a minimum of 12 to 18 months delay is anticipated,” Roche said in a statement.
It had been aiming to file taspoglutide worldwide in 2011.
Roche shares fell 2.3 percent by 0725 GMT on the news, while Ipsen — a much smaller company whose fortunes are tied closely to the experimental compound — tumbled 16 percent.
The most common symptoms in patients with hypersensitivity reactions were skin reactions and gastrointestinal symptoms, while cardiovascular and respiratory symptoms were less frequent. All patients recovered without complications.
Roche has said in the past that taspoglutide could see peak sales of at least 2 billion Swiss francs ($1.77 billion) if it gets to market.
The once-weekly injection would be a rival for Eli Lilly and Amylin’s Byetta and Novo Nordisk’s Victoza, the two established GLP-1 drugs. Several other drugmakers also have experimental GLP-1s in development.
Novo shares rose 3.5 percent in early trading.
Roche exercised its licensing option for taspogludie from Ipsen in 2006 and acquired exclusive worldwide rights to develop and market the drug, except in Japan where these rights are shared with Teijin and in France where Ipsen has retained co-marketing rights.
q     q     q
Bone drug: Britain’s health cost watchdog has recommended Amgen’s new drug Prolia, or denosumab, as a treatment for the brittle bone disease osteoporosis in women who cannot take the older class of bisphosphonate drugs.
The National Institute for Health and Clinical Excellence (NICE), which decides which drugs should be paid for on the state-funded National Health Service, said the twice-yearly injection was a cost-effective option for such patients.
The endorsement from NICE, whose decisions are watched closely by insurers and governments in other countries, is a boost for a medicine that is viewed as a key growth driver for Amgen, the world’s biggest biotechnology company.
Analysts estimate the product could see annual global sales of $3.3 billion in 2014 for all its uses, according to Thomson Reuters data.
The drug was given a marketing green light by the European Commission last month and costs 366 pounds ($537) for a year’s treatment. GlaxoSmithKline will help commercialise it in Europe.
Prolia is the first in a new class of drugs designed to inhibit proteins that activate bone-destroying cells and will compete in the osteoporosis market against a number of established bisphosphonate products.
These include Merck & Co’s Fosamax; Novartis’s Reclast; Warner Chilcott’s Actonel; and Glaxo’s own product Boniva or Bonviva, which it sells with Roche.
The oral versions of these drugs are not suitable for everyone, since patients have to remain standing or sitting upright for half an hour after taking the drugs. Some women may also be on drugs that react adversely with bisphosphonates.
q     q     q
Bladder control drug:  Japan’s Aste-llas Pharma (4503.T) said on Friday it was seeking approval from Japanese health authorities for a bladder control drug.
The company said it was seeking approval for the drug, known as mirabegron or YM178, to treat urinary frequency and urge urinary incontinence associated with an overactive bladder.
q     q     q
Cancer drug: Britain’s health watchdog NICE has rejected Zeltia’s drug Yondelis for ovarian cancer, arguing that the Spanish biotech company failed to provide sufficient evidence it is any better than standard treatment.
The National Institute for Health and Clinical Excellence (NICE) rules on which drugs should be paid for on the state-funded National Health Service. Its decisions are followed closely by insurers and governments in other countries.
Paclitaxel in combination with platinum-based chemotherapy is currently the most commonly used therapy for the kind of patients that Zeltia hopes to treat with Yondelis, which is also known as trabectedin.
“Unfortunately, the manufacturer did not provide any evidence directly comparing trabectedin with this combination of drugs,” NICE Chief Executive Andrew Dillon said.
Instead, Zeltia’s drug was compared with less common treatments. NICE experts were also worried that Yondelis was associated with high rates of toxicity on the body’s blood system.
“It was these factors and not necessarily the cost of the treatment that concerned the committee most,” Dillon said.
NICE’s preliminary guidance is available for public consultation until July 9.
q     q     q
Pink pill: A pink pill marketed by German drug firm Boehringer Ingelheimas a libido-booster for women has produced inconclusive results in two clinical trials, the US Food and Drug Administration (FDA) said.
Originally intended as an anti-depressant, the drug flibanserin — in the form of a pink pill — began being tested years ago as a potential libido aid after women said it failed to fight the blues but did boost their sex drive.
Lack of desire is the most common sexual problem in women aged 30 to 60, just as erectile dysfunction is the most common sexual disorder among men in the same age bracket, researchers said.
Clinical trials to test flibanserin’s efficacy in raising the level of sexual desire in women were held in Canada, Europe and the United States.
The results of two US trials with the drug and a placebo were published on the FDA’s website: “both failed to demonstrate a statistically significant improvement on the co-primary endpoint of sexual desire,” said the FDA.
“Therefore, neither study met the agreed-upon criteria for success in establishing the efficacy of flibanserin for the treatment of HSDD (hypoactive sexual desire disorder),” the administration added.
Besides the inconclusive results, the FDA noted the drug in some patients caused side effects including depression and dizzyness.
The FDA said its is waiting for recommendations on the little pink pill from an independent panel of experts due to report on Friday. The administration is not legally bound to comply with the advice, but usually does.
Boehringer Ingelhein has been researching flibanserin as a treatment for post-menopausal HSDD in women since the popular Viagra hit the market for male ED in 1998.