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"Between March 14, 2012 and March 16, 2012, Global Grid purchased an aggregate of 113,494,743 shares of Common Stock on the open market at an aggregate purchase price (excluding trading commissions and related administrative costs) of $3,658,274.15, as follows:
—
On March 14, 2012, Global Grid acquired an aggregate of 11,894,651 shares of Common Stock at a weighted average price of $0.01 per share, at prices ranging from $0.009 to $0.013 per share.
—
On March 15, 2012, Global Grid acquired an aggregate of 25,000,000 shares of Common Stock at a weighted average price of $0.02 per share, at prices ranging from $0.01 to $0.02 per share.
—
On March 16, 2012, Global Grid acquired an aggregate of 76,600,092 shares of Common Stock at a weighted average price of $0.04 per share, at prices ranging from $0.02 to $0.06 per share."
http://ih.advfn.com/p.php?pid=nmona&article=51710654
YRC Worldwide Poised To Triple
"The average Enterprise Value (EV) to EBITDA ratio for the trucking industry was calculated as 9.9; taking out, the two outliers FFEX and ABFS with ratios over 32 gets us to an average of 7.9 for the rest of the group (not including YRCW, FFEX and ABFS). In the case of YRCW, the company in their prior earnings report already projected FY 2011 EBITDA of $210 million. Apply that to a conservative 7.9 EV/ EBITDA multiple gives us a target price of almost 15 cents, three times above current prices. Of course, this is based on a very conservative calculation of (1) including all of the preferred convertibles in the share calculation, including those that can be converted only after July 22nd, 2013; (2) assuming an EBITDA of only $210 million which the company has projected to 2011. Historically, YRCW has generated EBITDA of between $500 and $800 million in the period from 2004-06. Assuming that they generate even two-thirds of the middle of this range will lead us to a target EBITDA sometime in the near future of almost $450 million. At that price, our target for YRCW would be 30 cents."
http://seekingalpha.com/article/297926-yrc-worldwide-poised-to-triple
News & Events - Alpha Biologics
"Michelle Peake is speaking on "Design Features of a Biopharmaceutical cGMP Facility to Reduce the Time and Cost to Market" at the 4th World Congress on Industrial Biotechnology, 25-29 April 2011, Dalian, China"
http://www.alphabiologics.com/news/
New NT 10-K Filing
"The Registrant has completed an acquisition during 2010 for which audited financials statements had to be completed and said statements consolidated within its own financials. Company expects to be able to disclose all late reports plus audited statements before June 30, 2011"
http://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=7836091
Last report:
(i) Period end date;
12/31/2011
(ii) Number of shares authorized;
RAMO = 200,000,000 Common Shares
(iii) Number of shares outstanding;
200,000,000 Common Shares
(iv) Freely tradable shares (public float);
33,007,671 Common Shares
http://www.otcmarkets.com/otciq/ajax/showFinancialReportById.pdf?id=45764
(ii) Number of shares authorized;
RAMO = 200,000,000 Common Shares
not 1 Biln
+34.375% - Frankfurt
PRICE: 0.043 EUR >>>> $ 0,058
http://www.bloomberg.com/apps/quote?ticker=VI5:GR
Drug Maker Ups Sales View
HEALTHCARE: Spectrum sees big gain, driven by key drugs
Fusilev: sales up amid production issues at rival
By Vita Reed
Sunday, February 20, 2011
Irvine drug maker Spectrum Pharmaceuticals Inc. said last week it expects fourth-quarter revenue to come in at nearly twice as much as analysts had been expecting.
Spectrum’s quarterly sales could come in at more than $33 million, the company said, up from about $9 million a year earlier.
Wall Street analysts on average had been projecting $16.3 million in fourth-quarter sales.
The drug maker’s fourth-quarter and 2010 results are due in mid-March.
Investors liked the news. Spectrum’s shares rose about 8% last week to a market value of $350 million.
The company’s shares are up nearly 50% in the past 12 months on optimism about growing sales and drugs in development.
Drugs
The higher sales forecast was driven by cancer drugs Zevalin and Fusilev.
Zevalin, which is used for treating non-Hodgkin’s lymphoma, a blood cancer, hit a yearly sales target of $27 million to $29 million, the company said.
The drug could grow into a blockbuster if Spectrum gains Food and Drug Administration approval to use it as a first-line non-Hodgkin’s lymphoma treatment, according to analysts.
Zevalin now is approved for treating the disease when other drugs have failed, or in conjunction with other drugs.
Spectrum is the fourth company to own Zevalin since it got FDA approval in 2001. The drug’s had issues that slowed sales for previous owners, including the danger of handling a radioactive drug for healthcare workers and patients.
“I think, finally, the stars are aligning for Zevalin,” Spectrum Chief Executive Rajesh Shrotriya said in an earlier interview. “Because now, there are more and more patients, and more doctors, comfortable using the drug.”
Spectrum’s other big drug, Fusilev, is used to treat osteosarcoma, a rare form of bone cancer.
Fusilev, which came out in 2008, was Spectrum’s first branded drug. Prior to 2008, the company mainly focused on generics.
Fusilev is seen growing amid production issues for a similar generic drug from Teva Pharmaceuticals Industries Ltd., according to Ren Benjamin, an analyst with New York investment bank Rodman & Renshaw.
Teva, an Israeli company with an Irvine plant, has faced production contamination problems with its leucovorin generic drug in recent years.
Leucovorin, which is considerably cheaper than Fusilev, has seen shortages.
The FDA is considering Spectrum’s request to use Fusilev as a treatment for patients whose colorectal cancer has spread. A decision is expected by the end of April.
Spectrum’s also working on new drugs.
In January, the company said it planned to develop what’s known as a “biosimilar” version of rituximab, a blockbuster cancer treatment developed by Switzerland’s Roche AG.
Biosimilars are different from generic versions of drugs because no two biotech drugs can be exactly the same.
Spectrum is working with Irvine drug maker Viropro Inc. to develop the biosimilar of rituximab.
http://www.ocbj.com/news/2011/feb/20/drug-maker-ups-sales-view/
Drug Maker Ups Sales View
HEALTHCARE: Spectrum sees big gain, driven by key drugs
Fusilev: sales up amid production issues at rival
By Vita Reed
Sunday, February 20, 2011
Irvine drug maker Spectrum Pharmaceuticals Inc. said last week it expects fourth-quarter revenue to come in at nearly twice as much as analysts had been expecting.
Spectrum’s quarterly sales could come in at more than $33 million, the company said, up from about $9 million a year earlier.
Wall Street analysts on average had been projecting $16.3 million in fourth-quarter sales.
The drug maker’s fourth-quarter and 2010 results are due in mid-March.
Investors liked the news. Spectrum’s shares rose about 8% last week to a market value of $350 million.
The company’s shares are up nearly 50% in the past 12 months on optimism about growing sales and drugs in development.
Drugs
The higher sales forecast was driven by cancer drugs Zevalin and Fusilev.
Zevalin, which is used for treating non-Hodgkin’s lymphoma, a blood cancer, hit a yearly sales target of $27 million to $29 million, the company said.
The drug could grow into a blockbuster if Spectrum gains Food and Drug Administration approval to use it as a first-line non-Hodgkin’s lymphoma treatment, according to analysts.
Zevalin now is approved for treating the disease when other drugs have failed, or in conjunction with other drugs.
Spectrum is the fourth company to own Zevalin since it got FDA approval in 2001. The drug’s had issues that slowed sales for previous owners, including the danger of handling a radioactive drug for healthcare workers and patients.
“I think, finally, the stars are aligning for Zevalin,” Spectrum Chief Executive Rajesh Shrotriya said in an earlier interview. “Because now, there are more and more patients, and more doctors, comfortable using the drug.”
Spectrum’s other big drug, Fusilev, is used to treat osteosarcoma, a rare form of bone cancer.
Fusilev, which came out in 2008, was Spectrum’s first branded drug. Prior to 2008, the company mainly focused on generics.
Fusilev is seen growing amid production issues for a similar generic drug from Teva Pharmaceuticals Industries Ltd., according to Ren Benjamin, an analyst with New York investment bank Rodman & Renshaw.
Teva, an Israeli company with an Irvine plant, has faced production contamination problems with its leucovorin generic drug in recent years.
Leucovorin, which is considerably cheaper than Fusilev, has seen shortages.
The FDA is considering Spectrum’s request to use Fusilev as a treatment for patients whose colorectal cancer has spread. A decision is expected by the end of April.
Spectrum’s also working on new drugs.
In January, the company said it planned to develop what’s known as a “biosimilar” version of rituximab, a blockbuster cancer treatment developed by Switzerland’s Roche AG.
Biosimilars are different from generic versions of drugs because no two biotech drugs can be exactly the same.
Spectrum is working with Irvine drug maker Viropro Inc. to develop the biosimilar of rituximab.
http://www.ocbj.com/news/2011/feb/20/drug-maker-ups-sales-view/
Insider Trading activities: Viropro Inc
http://www.insider-monitor.com/trading/cik703901.html
FDA Says Rules for Copying Amgen Biotechnology Drugs to Arrive `Very Soon'
http://www.bloomberg.com/news/2011-02-18/fda-says-rules-for-copying-amgen-biotechnology-drugs-to-arrive-very-soon-.html
FDA seeks increase funding for biosimilar drugs initiative
FDA will develop a pathway called 'Protecting Patients Initiative' for approving biosimilars, which are biological drugs shown to be highly similar to, and without clinically meaningful differences with, an FDA-approved reference biological product. Such biosimilars may also be shown to be interchangeable with the FDA-approved reference biological product.
These biosimilars offer the potential of significant savings for government and private sector healthcare systems that provide care to millions of Americans. The Protecting Patients Initiative also strengthens FDA efforts to modernize and improve safety throughout the supply chain of medical products, and it contains other resources to assure the safety of medical products.
Teva Pharmaceutical Industries Ltd. is testing a copy of Roche’s second-biggest-selling drug Rituxan.
Spectrum Pharmaceuticals signed an agreement with Canadian partner Viropro to develop a version of rituximab ahead of its US patent expiration in 2015.
Novartis/Sandoz has a Phase II trial for its version of Rituxan (rituximab) and is focusing on patients suffering for rheumatoid arthritis.
LINK HERE
February 14th, 2011
http://cllcanada.ca/2010/index.htm
Follow-on Biologics Grow in India
Feb 22, 2011
By: A. Nair
In a bid to control the $16-billion market for insulin before 2015, when a number of antidiabetic drugs will lose their patent protection, Pfizer entered into a $350-million deal with Bangalore-based Biocon for the commercialization of four insulin products. Biocon's follow-on biologic versions of insulin and insulin-analog products (recombinant human insulin, glargine, aspart, and lispro) are already available in India.
"Our decision was timely," said Biocon Chairperson KiranMazumdar Shaw. "Biosimilars are gaining a lot of traction in the United States. The deal will help us emerge stronger in follow-on biologics as well as in the diabetes segment," she said.
Jumping on the follow-on biologics bandwagon
Biocon's deal with Pfizer, which closed in October 2010, was just one of the many biotech-based deals that Indian drug manufacturers have been making with Big Pharma companies around the world. Dr. Reddy's Laboratories (Hyderabad), Ranbaxy (Gurgaon), Shantha Biotech (Hyderabad), and Serum Institute (Pune) are actively involved in the follow-on biologic space, and analysts and investment bankers maintain that additional Indian drug companies such as Panacea Biotech (New Delhi), Intas Biopharmaceuticals (Ahmedabad), Reliance Life Sciences (Navi Mumbai), Bharat Biotech (Hyderabad), and Lupin (Mumbai) stand to benefit significantly given their portfolio of biotech drugs.
Tarun Shah, Asia head of Mehta Partners, the strategic business advisor to Japan's Daiichi Sankyo in its 2008 majority stake in Ranbaxy Laboratories, said, "Bringing a biosimilar drug to market is no easy task. It costs 20 times more than [small-molecule] generics." (Of note, Mehta Partners has raised equity for Intas Biopharmaceuticals.)
DhananjayPatankar, COO of Intas Biopharmaceuticals, however, believes that the entry of Indian follow-on biologics manufacturers into the global market could help to decrease exorbitant healthcare costs, especially in the United States.
Given the mounting pressure from governments and patients' groups to reduce the cost of medicine, biopharmaceutical companies that develop biologic drugs have a lot to offer. Herceptin (trastuzumab), for instance, which is a treatment for some forms of breast cancer, can cost as much as $48,000 for one year's worth of treatment, according to industry sources.
Shah points out that the US patent for rituximab (a monoclonal antibody against the protein CD20, for the treatment of rheumatoid arthritis and non-Hodgkins lymphoma) is due to expire in between 2015 and 2018. The product is marketed as Rituxan/Mabthera by Biogen Idec and Roche, respectively. The patent expiry creates opportunities for follow-on biologics manufacturers such as Intas. California-based Spectrum Pharmaceuticals and Viropro, a biopharmaceutical manufacturer, also teamed up on Jan. 5, 2011, to develop a follow-on version of Roche and Biogen Idec's rituximab. "The deal follows a 2007 agreement with Intas Biopharmaceuticals to become Viropro's second monoclonal antibody contract," explained Shah.
Speaking about a recent survey on Type 2 diabetes patients in the US, he noted that 60% of insulin users surveyed were eager to switch to a less expensive [follow-on] form of insulin as soon as the agent became available.
Dr. Reddy's Laboratories launched at a steep discount its first follow-on biologic product, Grafeel (filgrastim), which is used to treat cancer patients suffering from chemotherapy-induced neutropenia, in 2001, in India and its second, Reditux (rituximab) in April 2007. The latter was similar to Amgen's Neupogen to treat neutropenia, a lack of certain white blood cells caused by cancer or bone marrow transplant. This was followed by a third follow-on product, Cresp (darbepoetinalfa, a modified version of epoetinalfa), which the company touts as the first generic darbepoetinalfa drug in the world, used in the treatment of anemia due to chronic kidney disease.
The company intends to market Reditux in other regions, including the US, upon patent expiry of Amgen's Neupogen, according to a company presentation. Managing Director Satish Reddy said the Cresp launch effectively afforded the firm a sharper edge in marketing to the developed world.
Mumbai-based Cipla is also looking to launch follow-on biologics in the US market. Cipla Chairman YusufHamied says the firm is developing a range of discounted biosimilars. First off the block will be copycat versions of two of Roche's biologics: Avastin (bevacizumab) and Herceptin (trastuzumab), which target the treatment of breast cancer. Third will be a follow-on version of Enbrel (etanercept), a Pfizer/Amgen product that treats rheumatoid arthritis. "These [drugs] are very expensive today. When Cipla launches its biosimilars, these big companies (multinationals) will be forced to pull down their price," says Hamied. Together, the three drugs account for $19 billion in annual revenue.
Accounting for regulatory delays
Kamal K. Sharma, managing director of Mumbai-based Lupin, says "Once clarity emerges on the regulatory front, especially in the US, biosimilar drugs could provide a huge potential. However, data exclusivity in the US market [remains] a severe challenge," said. The company expects to launch its first follow-on biologic product in India this year.
According to the research firm Nomura Equity Research, between 2008 and 2015, biopharmaceuticals worth $59 billion are set to lose patent protection globally. From 2012, the follow-on biologics market is expected to add an estimated $10 billion in incremental revenues each year until 2020. In the US, the Congressional Budget Office recently estimated that potential savings on biologic drug products in the US between 2009 and 2014 could be as high as $25 billion, once a pathway for approval and marketing follow-ons is implemented. The fact is, although some of the drugs targeted for follow-on versions have garnered billions of dollars in sales for the original manufacturers, cashing in for Indian companies would be "no walk in the park," says Cipla'sHamied. Much rests on the implementation of the follow-on biologics pathway in the US.
While the US sorts out its implementation plan, some Indian firms are focusing on Europe in the short term. For example, Biocon's Shaw said the firm is in the process of registering its insulin for the European market and has licensed its G-CSF (granulocyte colony stimulating factor) to a North American firm and to AbraxisBioScience for the European market. Biocon is in the midst of setting up a marketing office in London, making Europe its focus during the next 12 months.
RanjitKapadia, vice-president of the institutional research firm HDFC Securities in Mumbai, adds that, because the "US law will take a while to be implemented and could undergo some revisions, Indian companies will not be able to launch their biosimilar anytime soon. And that is why the Biocon deal with Pfizer makes perfect sense. They have sold the rights to Pfizer. Now, Pfizer will have to fight to market their biosimilars in the US, whereas the Indian firm can sit pretty."
ABOUT THE AUTHOR
A. Nair
Articles by A. Nair
http://biopharminternational.findpharma.com/biopharm/Follow-on-Biologics-Grow-in-India/ArticleStandard/Article/detail/708305?ref=25
Global Biosimilars Market to Reach US$4.8 Billion by 2015, According to a New Report by Global Industry Analysts, Inc.
Biopharmaceutical market in World
Industry news
PR Web
1 day ago
San Jose, CA (Vocus/PRWEB) February 14, 2011 Biosimilars have remained a controversial subject in the global pharmaceutical industry, and continue to remain so even in the current environment. However, with the sector promising significant cost savings to the industry, several major markets are welcoming biosimilar legislations for the development of biosimilars. Consequently, biosimilars are expected to grow into a multi-billion dollar market in future. The already expired patents of biologics, such as Epogen, Neupogen and Enbrel, and the near term patent expiry of the currently leading biologics, such as Herceptin and Avastin, would help the global biosimilars market gain traction and expand wings across the globe. The absence of widespread legislations for biosimilars is primarily due to the complexity of biological drugs, as compared to the small molecule drugs. Production of biosimilars is also marred with huge technological investments and other clinical entry barriers, which is not the case with generic copies of small molecule drugs. The high-cost and complex technology involved in the production of biosimilars also restricts biosimilar companies from offering huge price discounts. As a result, a well-established regulatory framework, as seen in most countries for the approval of small molecule generics, is conspicuously absent in case of biosimilars, except in Europe and Japan, and recently in the US. The regulatory agencies, across the rest of world, have been adopting...
© 2011 PR We
Read more: http://news.reportlinker.com/n06146103/Global-Biosimilars-Market-to-Reach-US-4-8-Billion-by-2015-According-to-a-New-Report-by-Global-Industry-Analysts-Inc-.html#ixzz1E2463TrK
February 15, 2011 - The Spectrum Pharmaceuticals presentation is at 3:30p.m. Eastern Time on Tuesday
http://www.thestreet.com/story/10999819/1/spectrum-pharmaceuticals-to-present-at-the-bio-ceo-investor-conference.html
0.0675 - close, new high
0.0669 + 0.0159 (+31.18%) - new high
$ 0.066 +0.018 (+37.50%)
Frankfurt 28.571%
PRICE: 0.045 EUR >>> 0,06 $
http://www.bloomberg.com/apps/quote?ticker=VI5:GR
search on google for "viropro" "last 24 hours"
JANUARY 31, 2011, 3:46 A.M. ET - update - WSJ article
http://online.wsj.com/article/SB10001424052748703833204576113863804531534.html
Will Antibody Biosimilars See the Light of Day?
Analysis & insight: Jan 31, 2011
(Page 1 of 1)
Drug manufacturers have pressed on with advancing complex biosimilars including therapeutic mAbs into the clinic despite regulatory uncertainty and the potentially stiff costs attached to their manufacture. Biosimilar antibodies represent a multibillion-dollar opportunity for generic manufacturers both in the U.S. and Europe. Innovators, on the other hand, have a lot to lose if their blockbusters face market competition once they come off patent.
While the U.S. is setting up its regulatory framework, the EU has an approval process in place and is working on guidelines for antibodies and other more complex biologics. Over 10 biosimilars have been approved in the EU, including Omnitrope, a growth hormone developed by Novartis’ Sandoz and approved as a biosimilars to Pfizer’s Genotropin (somatropin), and Zarzio, Sandoz’ granulocyte colony-stimulating factor developed as a biosimilar to Amgen’s Neupogen (filgrastim).
None of the currently sanctioned biosimilars come close to antibodies in terms of manufacturing challenges, current therapeutic antibody producers are quick to point out. Roche/Genentech, maker of Rituxan, says on its website that due to the complexity of biologics as well as the distinctions introduced by differing manufacturing processes, it believes that each biosimilar “must be shown to be safe and effective on the basis of its own adequate and well-controlled clinical studies.”
The company also says it believes that biosimilar products “should only be approved initially for the indication that is directly supported by the nonclinical and clinical safety and efficacy data package submitted by the sponsor.”
MedImmune believes “That biosimilars, once approved, should have FDA-approved risk management plans to ensure the products are rigorously monitored for post-market safety and immunogenicity. If biosimilars are approved with less clinical data than innovator biologics, the FDA should ensure that longer-term post-marketing outcomes for biosimilars remain similar to those with the innovator product.”
Manufacturing Hurdles
For potential manufacturers of biosimilar therapeutics like antibodies, the financial incentives may be worth the effort. Johnson & Johnson’s Remicade generated 2009 sales of $4.3 billion, while Roche’s Rituxan made $5.5 billion and Herceptin made $14.4 billion in 2009. Patents for Remicade expire in 2018 in the U.S. and 2014 in Europe. Herceptin and Rituxan patents expire in Europe in 2014 and 2015, respectively, and both expire in 2018 in the U.S.
Nonetheless copycats will have to bear a lot of manufacturing process pain as well as associated high costs. They will also need a high tolerance for uncertainty to get into the antibody biosimilar business. Production of biosimilar antibodies is significantly more difficult than conventional small molecule drugs and also relatively smaller approved biosimilars like growth hormones and erythropoietin look-alikes.
Minor changes in manufacturing for the biosimilar product compared to the reference product can contribute to differences in glycosylation, aggregation, and protein folding. All of these can result in altered immunogenicity, antibody targeting, and, potentially, diminished therapeutic activity.
“Production technology is pretty standard for recombinant monoclonal antibodies,” Medimmune’s Gail Wasserman, Ph.D., svp of biopharmaceutical development, told GEN. “What makes the challenge different is that the innovator originally develops the manufacturing in parallel with carrying out nonclinical and clinical studies to establish safety and efficacy. During that time the innovator has the opportunity to identify the quality attributes of the product that are important for safety and efficacy.
“The makers of biosimilars, however, are confronted with the challenge of making a heterogeneous biological molecule similar to the innovator’s without the benefit of having development experience to understand the range of heterogeneity important for the safety and efficacy of the molecule,” Dr. Wasserman points out. “The innovator has insights, therefore, that the biosimilar developer may not.”
Regulatory Uncertainty
Thus far, the EMA has received requests for scientific advice on six biosimilar antibodies, including one from Teva for a biosimilar version of Rituximab.
Regulatory guidelines will not be the same as those for licensing of less complex recombinants like somatotropins and erythropoietins. In November 2010, EMA released new guidelines on biosimilar antibodies for a five-month public consultation period.
It is expected that the EMA guidelines will contain requirements for clinical trials of biosimilar mAbs. As yet the regulations don’t spell out the extent of the clinical testing needed to establish biosimilarity. The agency has not said whether the biosimilar antibody would also be interchangeable with the original.
“We do not support interchangeability between an innovator biologic and a biosimilar product,” states current antibody producer MedImmune. At this time regulations allow generic versions of small molecule drugs to be dispensed interchangeably with the original product at the pharmacy, without the approval of a physician.
Early commentary on EMA guidelines acknowledges that coming up with a “general framework is a near-impossible task in this subject area due to the many differences from one mAb to the next.”
One common thread does exist in EMA’s guidelines—comprehensive risk planning at the early stages. The guidelines particularly focus on the problems manufacturers may experience with current assays used to assess mAb immunogenicity, stating that detection of antibodies against mAbs using ELISAs or radio-immunoprecipitation may not be adequate because of nonspecific binding. It notes that a new generation of assays with the requisite sensitivity for use in clinical settings needs to be developed.
In November 2010, FDA held hearings to obtain input on the implementation of the Biologics Price Competition and Innovation (BPCI) Act of 2009. The act established an abbreviated approval pathway for biological products that are demonstrated to be highly similar to or interchangeable with an FDA-licensed biological product.
The BPCI act currently provides for up to 12.5 years of nonpatent market exclusivity for a biological product approved under a BLA consisting of an initial 12-year exclusivity period that may be extended by 6 months of pediatric exclusivity.
Some other standards will likely pose challenges for antibodies, in particular the standard for interchangeability. To meet this criterion “A sponsor must demonstrate that the biosimilar product can be expected to produce the same clinical result as the reference product in any given patient and, for a biological product that is administered more than once, that the risk of alternating or switching between use of the biosimilar product and the reference product is not greater than the risk of maintaining the patient on the reference product.” Since use of a biosimilar antibody could potentially preclude the use of the reference product in the same patient due to development of antiantibody antibodies, this regulation sets a high bar.
The guidelines are now open to public comment until May 31. Predictably, current manufacturers with products to protect took a fairly hard line on regulations for biosimilars in general. The Pharmaceutical Research and Manufacturers of America (PhRMA) along with some of brand-name drug makers told the FDA over the course of the two-day hearing that the science is “too lacking” at this point for the FDA to decide that some biosimilars are interchangeable with the original biologic.
Rituxan in the Crosshairs
Nonetheless, as the market for biosimilars in the U.S., Europe, and Japan is projected to exceed $2 billion by 2015, biosimilar antibody manufacturers remain undeterred. Market expansion is inevitable as patents expire, demand for cost-effective therapeutics increases, and the need for biologic drugs to treat chronic and complicated conditions of an aging population grows.
As analysts predicted, Rituxan is an early target for biosimilar developers. Rituxan, marketed in the EU as MabThera, is used to treat rheumatoid arthritis and relapsed or refractory low-grade or follicular CD20+ non-Hodgkin lymphoma.
Sandoz announced on January 10 that it has begun a Phase II trial in rheumatoid arthritis with a Rituxan biosimilar. Sandoz also reported that it has developed a high-yield and large-scale process for producing the biosimilar at its facilities in Schaftenau, Austria.
Teva, the largest generic drugmaker, formed a biosimilar partnership with Swiss contract manufacturer Lonza in January 2009. Teva’s TL011 is being developed as a biosimilar to Rituximab. The company has clinical trials under way in rheumatoid arthritis and non-Hodgkin lymphoma.
In addition, on January 6, Spectrum Pharmaceuticals said it plans to develop its own biosimilar version of Rituxan with its Canadian partner Viropro.
Costs Involved and ROI
The potential cost of making biosimilar antibodies will restrict it to a few companies with deep pockets. Developing a biosimilar mAb for one indication will be about $100 million, estimates the research group Collins Stewart. Starting from scratch, novel therapeutic antibody development takes between 8 and 16 years to complete and costs between $500 million to $1 billion.
Additionally, biosimilar drugs, particularly antibodies, may not produce the cost savings associated with small molecules or less complicated biologics. Generic medicines have saved the EU an estimated €20 billion annually, according to the European generic association, but biosimilars are not generics. Analysts expect price discounts of only 20 to 30% in markets affected by biosimilar competition. Compare that to the average 90% markdown for generic versions of small molecule drugs.
Biosimilar developers will have to find a way to gain a sufficient return on large investments made in development and manufacturing. At the same time biosimilars will have to be marketed at a price that incentivizes payers. Before all that, companies will have to prove, be it through the full slew of preclinical and clinical trials or an abbreviated process, that biosimilar antibodies can achieve the same clinical results as the reference products.
Patricia F. Dimond, Ph.D. (drpdimond@genengnews.com), is a principal at BioInsight Consulting.
Generics Companies Weigh In on Biological Drugs
JANUARY 30, 2011, 4:13 P.M. ET
ZURICH—Generic drug makers are expecting copies of complex biological drugs to become a multibillion dollar market in the near future. But a lack of clear regulation, intense scrutiny from makers of the original drugs and the high cost of research may damp their prospects.
Hopes that the U.S. and European market for these copies, known as biosimilars, will thrive are based on the fact that biological drugs with more than $60 billion in annual sales will lose patent protection by 2015, according to research firm Datamonitor.
Should the market develop according to plan, copies of these complex drugs alone could make up around 50% of the expected $10 billion biosimilars market by 2016, according to data compiled by Capgemini Consulting. The rest will come from simpler biosimilars, such as copies of insulin and human growth hormone.
Biological drugs are made of larger molecules than chemical drugs. They are generally more effective in treating diseases such as cancer but are more expensive because of the high costs involved in making them.
Among those with patents due to expire soon are Roche Holding AG's blood cancer and rheumatoid arthritis medicine Rituxan, also known as MabThera, anti-inflammatory drug Remicade, which is co-marketed by Merck & Co. and Johnson & Johnson, and Amgen Inc.'s and Pfizer Inc.'s rheumatoid-arthritis drug Enbrel. Each drug had more than $5 billion in annual peak sales.
The European expiry in 2014 of Roche's Rituxan, a complex monoclonal antibody, which allows for the direct targeting of affected cells, has recently prompted three generic players to start research on a copy. Novartis AG's generics unit, Sandoz, said it has started midstage trials for the drug, following similar steps by U.S.-based Spectrum Pharmaceuticals Inc. in early January and Israel-based Teva Pharmaceutical Industries last year.
Sandoz, which is leading the market for biosimilars with a roughly 50% market share, ahead of Teva and U.S.-based Hospira Inc., expects the entire biosimilars business could reach more than $20 billion by 2020, up from a current $250 million. Swiss chemicals company Lonza Group AG, which is teaming up with Teva in its biosimilars venture, expects solid growth because patients, insurance companies and governments want drugs to be cheaper.
The generics companies base their argument on the high price of many complex biological medicines. Treatment with Roche's lung and kidney cancer drug Avastin and the colorectal cancer drug Erbitux from Germany's Merck KGaA can cost thousands of dollars a month. But some experts question the generics companies' pricing rationale, saying the current constraints could even force larger generic producers such as Sandoz or Teva to rethink their operating models.
"Much will depend on how the price of these drugs will develop," says David Kaegi, pharmaceuticals analyst at Bank Sarasin. "Depending on the price, operating models will have to be adjusted."
He says prices for biosimilars could be just 30% lower than the prices of the originals, because only a couple of generics firms will compete against an original drug. "It thus won't be like in the case of the simple generics, where many firms moved into the market and prices were aggressively cut. It will be more difficult," he says.
Since generics of chemical drugs, which are made of small molecules, are relatively simple to copy, the market for generic drugs attracted a flurry of players and this brought prices down sharply.
The main risk, analysts say, is that if prices don't come down much, original drug producers will be able to retain a large market share. On the other hand, if prices fall too fast, generics firms' margins could suffer.
A Sandoz spokesman said the company expects pricing to continue to vary according to product and market, saying the entry bar for complex products would be high, which would limit competition and keep prices from falling too fast. Lonza's chief executive, Stefan Borgas, said that even if prices fell by 50%, margins and growth would still be healthy.
Industry insiders and management consultants are also concerned the market may need longer than expected to establish itself, as research and development for these complex drugs is difficult and costly, and doctors and patients may be wary about their safety.
One of the main problems with generic versions of complex biological drugs is that, unlike simple-to-produce generics of chemical drugs, which are identical to the originator product, these medicines aren't exact copies. Complex biological drugs such as Rituxan are genetically engineered and consist of large molecules produced in live cells.
Because the manufacturing process is difficult, requiring extensive genetic expertise, and it is also prone to errors, continuous testing and controlling is needed. At best, a generic copy can only be similar to the original protein.
Because biosimilars aren't identical copies, "biotech and big pharma are looking to squash the movement by throwing bioequivalent issues and quality-control issues," says Mary Ann Crandall, an independent pharmaceutical analyst at research firm Kalorama Information. "I think that will continue to hinder things. These products are too much of a cash cow to just let generics come in and cannibalize it."
World-wide sales of all biological drugs reached $130 billion in 2009, according to research firm IMS Health, and are expected to grow much faster than conventional chemical drugs.
Another factor keeping the biosimilars market in check is the lack of clear regulatory guidelines.
While the European Medicines Agency has so far approved 13 simpler biosimilar drugs such as insulin, final guidelines for complex biosimilars are still pending. Analysts say they may be introduced next year.
In the U.S., regulators are currently working to establish how intensive testing for biosimilars needs to be and how the traditional three-phase drug-approval process for originals can be abbreviated. A key concern is to make sure that biosimilar drugs are safe and effective.
"I had predicted that it would be in place by 2009 but now, although there has been progress, there are still numerous regulatory hurdles. Big pharma is very influential and not about to go quietly," Ms. Crandall says.
Roche, which has already prepared for generics competition but expects the impact from biosimilars on Rituxan to be limited, says that while it supports the development of regulatory frameworks for biosimilars, patient safety is of the utmost importance.
"Specific processes, data, research and experience are needed to ensure that a biosimilar monoclonal antibody has the same profile, efficacy and safety as the originator product," Roche says.
This may prove too difficult for many players. Michael Frizberg, vice-president of Lonza Generics, said that developing a complex biosimilar can take up to eight years and cost more than $100 million.
Sandoz's head, Jeff George, put the cost as high as $250 million for difficult-to-copy large-molecule drugs.
Although small U.S. biotech Spectrum Pharmaceutical, which has teamed up with Viropro Inc., says it has enough funds to develop a copy of Roche's Rituxan—financial constraints may keep many smaller firms from entering the market. "It may cost too much time and money for a number of small to midsized generics manufacturers to embark on biosimilars production," says Stephane Dutu, asset manager at Vernes & Associés in Geneva.
"Furthermore," Mr. Dutu says, "doctors may be reluctant to use biosimilars as it is a new class of products with no track record in terms of safety and benefits." A poll conducted in summer 2010 by GMS Dr. Jung GmbH, Gesellschaft für Markt- und Sozialforschung, found that more than 50% of physicians in Germany have heard or read little or nothing about biosimilars.
Write to Goran Mijuk at goran.mijuk@dowjones.com
http://online.wsj.com/article/SB10001424052748703833204576113863804531534.html
Penny Stock of the Day; MultiCell Technologies Inc.
By Jacob Black on Jan 25, 2011 in Business
Shares of MultiCell Technologies Inc. (OTC: MCET) are soaring in today’s trading. The penny stock reached a 52-week high of $0.02 in mid-day trading, and at last check, it was up 33.04% to $0.0153, with volume up from daily average of 8.68 million to 91.52 million.
The penny stock of MultiCell Technologies has a 52-week range of $0.00-$0.02. The stock is currently trading above its 50-day and 200-day moving averages. It gained 159.32% in the last three trading sessions.
In November last year, MultiCell announced the receipt of cash grant awards under the U.S. government’s Qualifying Therapeutic Discovery Project program. The program was started by the Congress and offers a tax credit or grant equal to eligible costs and expenses for tax years 2009 and 2010.
Commenting on the grant, W. Gerald Newmin, Chairman and CEO of MultiCell, said that the company is pleased with its MCT-465 and MCT-475 drug development programs for the treatment of cancer. Newmin said that the company’s MCT-125 drug development for the treatment of fatigue in multiple sclerosis patients qualified for certification under the Qualifying Therapeutic Discovery Project.
MultiCell Technologies is a clinical-stage biopharmaceutical company, focusing on the development of novel therapeutics and discovery tools to address unmet medical needs for treatment of neurological disorders, hepatic disease and cancer.
http://www.techrockz.com/2011/01/25/penny-stock-of-the-day-multicell-technologies-inc/
Rumours on the Internet Push MultiCell Technologies, Inc.
http://pennystocknewsletter.info/hot-stock-tips/rumours-on-the-internet-push-multicell-technologies-inc-otcmcet-stock-steadily-up/
MultiCell hires CRO to manage MCT-125 phase IIb MS fatigue trial
http://www.msrc.co.uk/index.cfm/fuseaction/show/pageid/2354
COMMUNITY SENTIMENT
Top stocks creating buzz on Yahoo! Finance message boards
Bullish
Clinical Data, Inc. (CLDA)
MultiCell Technologies, Inc. (MCET.OB)
MIPS Technologies Inc. (MIPS)
http://finance.yahoo.com/
next VPRO ?!
Contact info (updated January 11, 2010):
Mr. Serge Beausoleil 514 779 7336: For IR and Market-related enquiries.
Mr. Claude Gingras 949 783 6573: For enquiries related to direct investment opportunities or Compliance
Dr Rajiv Datar 949 351 0860: For all other enquiries related to Corporate, Business and Scientific matters
http://www.viropro.com/index.php?module=CMS
Conference in New York City on Feb. 2, 2011
"Before taking off, Dr. Datar will attend the British Airways Face-of-Opportunity conference in New York City on Feb. 2, 2011 where the company will receive free counsel from top influential international business experts while networking with venture capitalists, renowned entrepreneurs, media and other small business owners."
http://www.viropro.com/modules.php?op=modload&name=News&file=article&sid=69
old news, but...
Viropro, Inc. Rated 'Outperform,' Target $2.60 by Beacon Equity Research.
Publication: Business Wire
Date: Thursday, July 27 2006
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Diosynth Biotechnology
Extensive breadth of process development and manufacture
www.biomanufacturingnetwork.com
DALLAS -- Viropro, Inc. (OTCBB:VPRO) has been rated "Outperform" with a target price of $2.60 by Beacon Equity Senior Research Analyst, Kris Goldcross, CFA.
The full report is available at http://www.BeaconEquityResearch.com
In the report Mr. Goldcross writes, "Viropro specializes in marketing its expertise in technology transfer for the industrial production of therapeutic proteins. The company's primary objective is to make therapeutic proteins (whose patents have expired) readily available to pharmaceutical partners located in emerging regions of the globe with unmet medical needs, including South America, Asia and Africa. The company is also focusing on the development and marketing of therapeutic vaccines against cancer or chronic infections such as AIDS."
"Given the company's exposure to the biotechnology industry, we have compared Viropro to similar publicly trading companies that are engaged in the production of therapeutic drugs. These include Lexicon Genectics, Inc. (Nasdaq:LEXG); Pharmaceutical Product Development, Inc. (Nasdaq:PPDI); Gilead Sciences, Ltd. (Nasdaq:GILD); Genzyme Corporation (Nasdaq:GENZ) and PDL BioPharma, Inc. (Nasdaq:PDLI)."
Beacon Equity Research Disclosure
The analysts contributing to this report do not hold any shares of Viropro, Inc. (VPRO). Additionally, the analysts contributing to this report certify that the views expressed herein accurately reflect the analysts' personal views as to the subject securities and issuers. The analyst(s) writing this report recognize and aspire to all of the CFA Institute Guidelines for Independent Research. Beacon Equity Research ("Beacon") certifies that no part of the analysts' compensation was, is, or will be, directly or indirectly, related to the specific recommendation or views expressed by the analysts in the report. Beacon has directly been compensated six-thousand dollars directly by Viropro for enrollment in its research program. This report is based on data obtained from sources we believe to be reliable, but is not guaranteed as to accuracy and does not purport to be complete. As such, the report should not be construed as advice designed to meet the particular investment needs of any investor. Any opinions expressed herein are subject to change.
Anyone interested in receiving alerts regarding Viropro, Inc. research should email members@beaconequityresearch.com with "VPRO" in the subject line.
http://www.allbusiness.com/science-technology/technology-transfer/5342854-1.html
Staying out of The Sub Penny Stock List
http://www.pinkinvesting.com/article/view/Viropro-Inc.-VPRO.PK-Staying-out-of-The-Sub-Penny-Stock-List
Insider Actions
is confusing to see (4) indicates that he sold, and after seeing other indications that he bought:
http://www.marketwatch.com/investing/stock/VPRO/insideractions
2011: The Year of the Biosimilar
"Monoclonal antibodies are considered an important and value-added part of the biosimilars pie, and a biosimilar rituximab is a likely first entry into this segment. The patents for rituxumab are expected to expire between 2015 and 2018 in the United States and in 2013 in the rest of the world, according to Biogen Idec’s 2009 annual report. Global sales of MabThera/Rituxan were CHF $6.1 billion ($6.1 billion) in 2009, according to Roche’s 2009 annual report. In addition to Sandoz, Teva Pharmaceuticals is developing a biosimilar version of rituxmab, according to a recent company investor presentation, and Mumbai-based Dr. Reddy’s Laboratories has developed a generic version for the Indian market, according to the company’s 2009 annual report. Smaller companies are also getting involved in the fray. The biopharmaceutical company Spectrum Pharmaceuticals announced on Jan. 5, 2011, that it signed a letter of agreement with Viropro, a company that develops cell lines and manufacturing processes for biosimilars, for the development and clinical production of a biosimilar rituxumab. Also, in a Bloomberg/Business Week article this week, Biogen Idec, itself, alluded to an interest in entering into the biosimilars market over the next several years although the company did not offer further specifics."
http://blog.pharmtech.com/2011/01/13/2011-the-year-of-the-biosimilar/
Contact info (updated January 11, 2010):
http://www.viropro.com/index.php?module=CMS
Roche shareholders have been concerned
"Some Roche shareholders have been concerned about plans by competitors to develop so-called biosimilar versions of Roche drugs."
http://www.nasdaq.com/aspx/stock-market-news-story.aspx?storyid=201101101326dowjonesdjonline000281&title=roche-to-defend-products-against-biosimilar-threat-cfo
Worldwide sales of all biologic drugs reached $130 billion in 2009
http://www.foxnews.com/health/2011/01/10/novartis-moves-ahead-drug-treat-non-hodgkins-lymphoma/
"Other companies are working on a biosimilar of Rituxan, notably Teva Pharmaceutical Industries, while last week Spectrum Pharmaceuticals signed a pact with Viropro to develop a version of rituximab"
"Novartis' Rituxan biosimilar goes into Phase II"
http://www.pharmatimes.com/Article/11-01-11/Novartis_Rituxan_biosimilar_goes_into_Phase_II.aspx
The Spectrum Pharmaceuticals presentation is at 12:00 p.m. Pacific Time on Thursday, January 13, 2011
http://www.thestreet.com/story/10967715/1/spectrum-pharmaceuticals-to-present-at-the-29th-annual-jp-morgan-healthcare-conference.html