Biodel - Marlboro für das Depot?
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Wertpapier: Albireo Pharma |
by zoomlik • Mar 18, 2016 2:17 PM
1-,cash .. 50 cents
2- quarterly burn .. 1.5 cents
3- biod-531 showed highly superior blood glucose level in phase 2 as compared to Humalog 75/25 mix .. See slide 23 of sept 2015 presentation
4- GEM showed highly superior from ease of use point of view as compared to existing .. See slides 6 to 9
5- remaining technical staff have been previously worked with Boehringer Ingelheim or Mannkind
6- The 8 decision makers for a potential deal have 1.7 million shares at 30 cents
7- building leases were renewed for only 3 months, suggesting deal expected to be closed before end of April
In the interim, even though Biodel's finances are quite sound for a biotech startup, there is already speculation that Biodel could well be sold to an established pharmaceutical company. Two names on the top of those speculators' lists: Eli Lilly & Co. or Sanofi-Aventis. While both of these companies already hold a dominant postition in the global insulin market, Lilly's insulin business continues to lose market share to Novo Nordisk (and to a slightly lesser extent Sanofi-Aventis), routinely being dropped to second-tier status from many insurance company formularies or being dropped altogether. What's more, the patent for Humalog (insulin lispro rDNA origin) expires about a year from now, and the prospect for generics has never been greater now that U.S. law is forcing the FDA to outline approval procedures for follow-on biopharmaceuticals. A meeting will be held at the FDA this month to discuss this issue further and resolve some outstanding concerns.
Lilly has no long-acting analogue to compete with Sanofi-Aventis' blockbuster Lantus (insulin glargine rDNA origin), which is the world's best-selling insulin variety representing $4.0 billion in sales each year, or Novo Nordisk's Levemir (insulin detemir rDNA origin), putting the company at a competitive disadvantage when insurers choose preferred insulin brands. For Sanofi-Aventis, Biodel has some technology that could not only make it's Apidra (insulin glulisine rDNA origin) work even faster (even though the patents for Apidra don't expire for a few more years), but also make it's mega-blockbuster Lantus (whose patent expires in 2014) work better by extending the profile (longer and "peakless") and/or adjustable, thus enabling a possible patent extension for a modified version of Lantus to potentially be sold down the road assuming it gains regulatory approval.
Why would either company want to buy Biodel when the company is basically re-tooling their existing products?
Simple, as these products reach the end of their patent lifecycles, the margins on these products will either be cut by at least 75% or more, or sales will go to new generic versions (the FDA calls them "follow-on" biologic medicines). Both Lilly's Humalog as well as Sanofi-Aventis' Lantus will expire soon (Novo Nordisk's Novolog/Novorapid also expires in 2013) and with companies like Novartis Sandoz unit, Teva Pharmaceutical Industries Ltd., as well as the Pfizer/Biocon deal announced this spring eager to sell generic versions of these products, it's safe to say that the losses to the companies' bottom lines will be quite severe.
Lilly, in particular, faces what has been called a "patent cliff". Not only does Humalog's patent expire in late 2012, but Lilly also faces generic competition for 4 of its 5 top-selling products including its schizophrenia drug Zyprexa, antidepressant Cymbalta, cancer drug Gemzar and osteoporosis treatment Evista. Sales of these drugs make up about half of the company's annual revenues. What's more, several Lilly's drugs in late-stage development (including an extended-release version of the type 2 drug exenatide that Lilly, along with partners Amylin Pharmaceuticals, Inc. and Alkermes, Inc. was calling Bydureon, as well as a type 1 diabetes autoimmunity drug called teplizumab being jointly developed with Macrogenics, Inc.) have all failed to meet their primary efficacy criteria. In April 2008, John Lechleiter, Lilly’s CEO cited teplizumab as one of three most promising experimental drugs in the company's pipeline. With those products unlikely to become blockbusters soon, that means the urgency for new drugs at the Lilly is even greater, and a small acquisition like Biodel might help to fill several huge voids in it's pipeline. It may work in selected segments of the sample population, but the prospects as a billion+ dollar drug seem dashed.
Sanofi's Lantus is a $4 billion drug whose patent expires in 2014, or for all practical purposes, a little over a year from now. That product is one where anything that can extend the patent would have huge financial implications, and Sanofi-Aventis has already stated it's desire to be the leader in the insulin space. Although it's rapid-acting analogue will enjoy patent protection until June 2018, the looming question is whether the advent of generic Humalog and Novolog varieties might destroy sales growth for Apidra? After all, if insurance companies can offer not one, but two alternatives for less, we can safely assume that Apidra's sales is probably NOT safe from biosimilars/follow-ons even though it enjoys patent protection for a few more years.
Ultimately, the delay in approval on Biodel's Linjeta is regrettable, but the finances for Biodel appear quite solid, and the pipeline looks very attractive for several big pharma companies who have not invested sufficiently in their insulin businesses in preparation for their eventual patent expirations, perhaps hoping they could delay regulators for many more years to come. In the meantime, the prospects for Biodel's products remain quite solid (additional trials on a small population might enable them to re-submit the application, although details won't be available until Biodel management meets with the FDA), it seems that Biodel's shares are now cheaper than they were before. For investors, this might be a good opportunity to pick up shares for a great price, with longer-term prospects of having the company sold to a bigger rival looking more likely with each coming day.
http://blog.sstrumello.com/2010/11/...ls-linjeta-is.html#.Vwd69Ydf19A
KK
Biodel (Nasdaq: BIOD )
Takeover chatter continues to swirl around this maker of an injectable insulin device that acts more quickly than existing devices. When the FDA pushed back and told Biodel in late October that it needed to conduct more tests, investors dumped shares, which have been stuck around $2 ever since. More clinical tests means more spending and likely more dilutive capital-raising later in 2011. Although Biodel was rumored to be in play for $15 to $20 a share a few years ago, management would likely be happy to take $6 or even $8 for the stock these days. Still, that would be a pretty hefty gain from the current share price.
Read more: http://www.nasdaq.com/article/...-buyout-rumors-cm68190#ixzz45EA7EubV
http://www.medgadget.com/2016/04/...ompetitive-landscape-and-etc.html
KK
Type 1 Diabetes Market: (2015 to 2021) – Industry dynamics, segmentation, Historical, current and projected industry trends, Competitive landscape and etc.
April 8th, 2016 Persistence Market Research Releases
logo2207Diabetes refers to a group of metabolic disease characterized by high blood sugar level. Diabetes occurs due to inadequate secretion of insulin inside the pancreas. Some of the common symptoms for diabetes are frequent urination, excessive thirst, increased hunger, weight loss and tiredness. Type 1, type 2 and gestational diabetes are three types of diabetes. Type 1 diabetes is an autoimmune disease occurred due to high blood glucose level whereas, type 2 diabetes is a lifelong chronic diseases caused due to excess secretion of insulin inside the body. In type 1 diabetes, the immune system is activated against self-insulin producing cells. This results into low production of insulin and also disrupts blood glucose homeostasis. In type 1 diabetes, exposure to viral infection such as mumps and coxsackie viruses results into pancreas damage which results into low insulin secretion. Type 1 diabetes is highly prevalent in young people and children whereas type 2 diabetes is common type of diabetes. Some of the common symptoms for type 2 diabetes are overweight, high blood pressure and high triglycerides. Diabetes is treated with the help of insulin delivery devices and drugs. Diabetes diagnostic devices includes analog blood meter, test strips, lancets and lancing devices whereas, insulin delivery devices includes insulin syringe, insulin pump, insulin pen and insulin jet injectors. Severe problems such as blindness, kidney failure, coronary heart disease and strokes may result due to lack of proper treatment.
North America is dominating the global type 1 diabetes market due to rising prevalence of diabetes. The U.S. is dominating the North American diabetes market. Asia Pacific region is expected to show high growth rate due to rising aging population in coming five years.
Interested in report: Please follow the below links to meet your requirements;
Request for the Report Brochure: http://www.persistencemarketresearch.com/samples/3706
In recent time there is increased use of insulin delivery devices due to rising number of chronic diseases associated with diabetes. Rising awareness among people and technological advancement in insulin delivery devices are some of the key factors driving the growth of the global type 1 diabetes market. In addition, increasing government initiatives for diabetes control is also fuelling the growth of the global type 1 diabetes market. However, high cost of diagnosis and treatment is restraining the growth of the global type 1 diabetes market. In addition, unfavorable reimbursement policies are also inhibiting the growth of the global type 1 diabetes market.
Request TOC (table of content), Figures and Tables of the Report: http://www.persistencemarketresearch.com/toc/3706
Side effects associated with diabetes therapies could lead a challenge for the global type 1 diabetes market. Strong pipeline and development of molecules from newer class of diabetes drugs would be an opportunity for the growth of the global type 1 diabetes market. In addition, development of non-invasive diabetes diagnostics and drug delivery devices would also develop an opportunity for the growth of the global type 1 diabetes market. Increasing demand for artificial pancreas and home infusion therapy for diabetes treatment are some of the trend for the growth of the global type 1 diabetes market. Some of the major companies operating in the global type 1 diabetes market are Eli Lilly and Company, Astrazeneca Plc., B.Braun Melsungen AG, Novo Nordisk A/S, Sanofi-Aventis US, LLC, DiaVacs, Inc., XOMA Corp., Biodel, Inc. and Macrogenics, Inc.
For more info: http://www.persistencemarketresearch.com/contact-us.asp
KK
... jetzt ist quasi nur die Frage was in Zeiten der 0 Zins-Politik mit "wesentlicher Wert" gemeint ist :-)
Der Kurs bekommt es irgendwie nur nicht mit.
Habe heute Morgen 100k gekauft, und merkst du auch nur einen winzigen Ausschlag am Kurs ??
Die werden auch nicht im Orderbuch angezeigt oO
Orderbuch der Börse Frankfurt angezeigt... Seltsam.
Hauptsache in meinem Depot eingebucht!