Momentum builds for biogenerics, execs say
Nina Andrikian
Reuters Health Summit
NEW YORK (Reuters) - Despite the failure by U.S. legislators to create a path this year for generic versions of biotech drugs, companies that have invested in the products tell Reuters such legislation could pass in 2008 and yield generic biologics early in the next decade.
Momentum is clearly building, generic drugmakers and other companies that could benefit from the arrival of generic biologics said at the Reuters Health Summit in New York this week.
“The wind is at our back,” Barr Pharmaceuticals (BRL) Inc Chief Executive Bruce Downey told Reuters. “We’ve really turned a corner in the last 15 months, and I think we’re well on our way to seeing legislation.”
U.S. legislators have been debating bills to create a pathway to approve generic forms of many drugs that are derived from naturally occurring proteins, known as biologics.
Such medicines are more complicated to manufacture than standard chemical drugs, making it difficult to determine whether they are equivalent to the originals.
“I really believe in ‘08 some type of legislation will be passed,” said Hospira Inc. (HSP) CEO Chris Begley at the Reuters Health Summit.
Others told Reuters it was difficult to predict the legislative process, especially in an election year, but were no less upbeat about an eventual law.
“You can’t predict what’s going to go on in Congress, but I do think it’s starting to resonate,” said Thomas Ryan, CEO of CVS Caremark Corp (CVS), the drug store chain and pharmacy benefit manager at the Reuters Health Summit.
BioHealth Investor.com
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Types of Advanced Fertility Therapies
by H.S. Ayoub, DMD
BioHealth Investor
Fertility treatment still remains relatively unregulated even in the westernized nations, including the U.S. A well written article on the current contraversy over the true value of such therapies in today’s edition of the Wall Street Journal summarizes the different procedures as follows:
(source: WSJ and SART.ORG)
In-Vitro Fertilization (IVF)
Egg is fertilized outside of the womb, then implanted in the uterus. Average cost is $30,000 per delivery. Live birth expectancy is 37.1% for women under the age of 35, while is is only 29.2% for those between 35 and 37.
IVF Using Donor Eggs
Healthy egg provided by another woman. Delivery rate: 52.1% for fresh embryo, 31.1% for thawed embryo.
IVF Using Thawed Embryo
Egg is fertilzed before the freezing process. Delivery rate: 31.9% for women under 35, and 27.9% for women between 35 and 37.
IVF Using Thawed Egg
Egg is not fertilized prior to freezing. Data is not sufficient, but preliminary results show that delivery rates range between 10% to 25%
Intra Cytoplasmic Sperm Injection
A single sperm is manually injected into an egg. Addressed male fertility problems, but some concerns do exist relating to increased chances of birth defects.
Pre-Implantation Genetic Diagnosis
The process of detecting single-gene mutation diseases. Clinically shown to be most useful for couples known to be disease carriers.
Pre-Implantation Genetic Screening
The process of screening for abnormal numbers of chromosomes in the genome. More useful for women who have history of multiple miscarriages, but more data needed for lower-risk women.
BioHealth Investor.com
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3SBio Rises after Reporting Q3 Results
by Richard Daverman, PhD
ChinaBio Today
For a change, a China-based biopharma has released a Q3 financial report that made investors happy, sending them out to buy the stock and push its price higher. 3SBio (SSRX) reported revenues that climbed 57% (year over year) to 56.1 million RMB ($7.5 million) and profits that jumped a large 151% to 24.1 million RMB ($3.2 million).
The shares of 3SBio responded by gaining 16% in the first post-report session, moving up $2.28 to $16.68. That was a different result than experienced by most China-based biopharmas recently. In the past few days, WuXi PharmaTech (WX), Tongjitang Chinese Medicines (TCM) and Simcere Pharmaceuticals (SCR) all dropped after reporting results that were much improved over the year before, but did no more than meet the high expectations of investors.
Breaking down its numbers, 3SBio said its mainstay product, TPAIO (a version of EPO), saw its sales rise 31% to 36.3 million RMB ($4.8 million). 3SBio’s newer product, the protein-based recombinant human thrombopoietin (TPO) TPAIO, had a much larger increase of 172%, but it still produced only 14.2 million RMB ($1.9 million). Earnings per share came in at 15 cents per ADS.
Looking into the future, 3SBio says it expects to complete the Phase III trial of Nuleusin, a high-dose (36,000 IU) version of EPIAO, by the end of 2007. The Phase III trial of TPIAO for idiopathic thrombocytopenic purpura should also be finished before the end of the year.
During Q3, 3SBio reported at a scientific meeting in China on two clinical trials of its in-licensed iron-sucrose supplement. Comparing the 3SBio drug with known IV-Iron supplements, the 3SBio candidate was found to have superior safety and similar efficacy as the other products. The company also beefed up its sales force, mostly in terms of training. They have their eyes on an additional 121 hospitals for 3SBio’s line of EPAIO products. In Q3, 3SBio was successful in introducing EPIAO into the 19 major hospitals of the Beijing military hospital system. 3SBio is also building up its export business as EPAIO is currently in the process of entering the national insurance reimbursement list of Thailand.
ChinaBio Today is a regular contributor to BioHealth Investor
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Monday’s Top Biotech & Medical Stocks
by H.S. Ayoub
BioHealth Investor
Biotechnology
QUESTOR PHARMACEUTCL [QSC] +46.56%
ACCENTIA BIOPHARMACE [ABPI] +16.36%
INNOVIVE PHARMACEUTL [IVPH.OB] +13.33%
MOLECULAR INS PHARMA [MIPI] +10.50%
HEMISPHERX BIOPHARMA [HEB] +9.77%
Diagnostic Substances
ISTA PHARMACTLS [ISTA] +14.88%
ICAGEN, INC. [ICGN] +4.03%
IMMUCELL CP [ICCC] +3.85%
REMOTEMDX INC [RMDX.OB] +3.59%
IMMUNOMEDICS INC [IMMU] +3.52%
Drug Delivery
QUIGLEY CORP THE [QGLY] +4.57%
NEKTAR THERAPEUTIC [NKTR] +4.13%
COLUMBIA LABS INC [CBRX] +2.67%
INSITE VISION INC [ISV] +0.88%
EMISPHERE TECH [EMIS] +0.52%
Drug Manufacturers
MARSHALL EDWARDS [MSHL] +10.62%
WUXI PHARMATECH ADS [WX] +8.42%
ALLOS THERAPEUTICS [ALTH] +5.57%
NEXMED INC [NEXM] +4.93%
ACETO CP [ACET] +3.60%
Drug Related Products
BOND LABORATORIES [BNDB.OB] +6.25%
ARGAN INC [AGX] +5.07%
INTEGRATED BIOPHARMA [INBP] +3.40%
IMAGENETIX INC [IAGX.OB] +3.39%
DRAXIS HEALTH INC [DRAX] +2.75%
Generic Drugs
CATALYST PHARMACEUTI [CPRX] +9.27%
ISOLAGEN INC [ILE] +3.45%
PHARMACUTICAL CO [PRX] +2.33%
CARACO PHARMA LABS [CPD] +1.42%
Medical Appliances & Equipment
BSD MEDICAL CORP [BSM] +3.70%
DEL GLOBAL TECH CORP [DGTC.OB] +3.45%
CRITICARE SYS INC [CMD] +3.38%
ROCKWELL MED TECHS [RMTI] +2.70%
LAKELAND INDS INC [LAKE] +2.36%
Medical Instruments & Supplies
VIVUS INC [VVUS] +9.03%
STRATEGIC DIAGNOST [SDIX] +7.71%
MILESTONE SCIENTIFIC [MLSS.OB] +5.00%
CAS MEDICAL SYS INC [CASM] +4.76%
APA ENTERPRISES [APAT] +4.67%
Medical Laboratories & Research
NEOGENOMICS INC [NGNM.OB] +9.56%
INSIGHT HLTH SVC HLD [ISGT.OB] +5.26%
ERESEARCHTECHNOLOG [ERES] +4.88%
ARRAY BIOPHARMA IN [ARRY] +3.00%
ALLIANCE IMAGING INC [AIQ] +2.36%
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Tuesday’s Top Biotech & Medical Stocks
by H.S. Ayoub
BioHealth Investor
Biotechnology
GTX, INC. [GTXI] +13.16%
SEQUENOM INC [SQNM] +11.57%
CHARLES RIVER LAB [CRL] +9.80%
INNOVIVE PHARMACEUTL [IVPH.OB] +8.67%
POLYDEX PHARM LTD [POLXF] +8.04%
Diagnostic Substances
RESPONSE GENETICS, I [RGDX] +15.74%
INTERLEUKIN GENETICS [ILI] +12.07%
ABAXIS INC [ABAX] +8.26%
PRESSURE BIOSCIENC [PBIO] +6.37%
IDEXX LABS [IDXX] +4.12%
Drug Delivery
NOVEN PHARMACEUTIC [NOVN] +3.37%
EMISPHERE TECH [EMIS] +2.55%
ELAN CP PLC ADR [ELN] +2.07%
NEKTAR THERAPEUTIC [NKTR] +1.86%
HOSPIRA INC [HSP] +1.80%
Drug Manufacturers
SANTARUS, INC. [SNTS] +13.16%
PLANET TECHS INC [PLNT.OB] +12.73%
NEUROGEN CP [NRGN] +12.67%
SIMCERE PHARMA ADS [SCR] +9.99%
ALLOS THERAPEUTICS [ALTH] +8.53%
Drug Related Products
CHINA SHENGHUO PHARM [KUN] +15.62%
INTEGRATED BIOPHARMA [INBP] +9.97%
DRAXIS HEALTH INC [DRAX] +3.50%
PERRIGO COMPANY [PRGO] +2.74%
TIENS BIOTECH GR USA [TBV] +2.55%
Generic Drugs
BARR PHARMA INC [BRL] +2.37%
MYLAN INC. [MYL] +1.14%
PHARMACUTICAL CO [PRX] +1.12%
LOTUS PHARMACEUTICAL [LTUS.OB] +0.88%
CATALYST PHARMACEUTI [CPRX] +0.67%
Medical Appliances & Equipment
SHAMIR OPTICAL INDUS [SHMR] +3.85%
DIGIRAD CORPORATION [DRAD] +3.69%
WORLD HEART CORP [WHRT] +3.44%
SYNOVIS LIFE TECH [SYNO] +3.25%
MINE SAFETY APPL [MSA] +3.15%
Medical Instruments & Supplies
OSTEOTECH INC [OSTE] +16.36%
CPC OF AMERICA INC [CPCF.OB] +9.38%
PRO-DEX INC NEW [PDEX] +6.06%
BIOSPHERE MEDICAL [BSMD] +5.92%
MINDRAY MEDICAL INTL [MR] +5.11%
Medical Laboratories & Research
[GXDX] +4.91%
ALLIANCE IMAGING INC [AIQ] +3.96%
ERESEARCHTECHNOLOG [ERES] +3.85%
MEDTOX SCIENTFIC INC [MTOX] +3.33%
GENOMIC HEALTH, INC. [GHDX] +3.12%
- Monday’s Top Biotech & Medical Stocks
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Hillary Clinton - Where the Candidates Stand on Healthcare
by Mark Senak
Eye On FDA
By contrast to most of the other candidates, the healthcare plan laid out by Senator Hillary Clinton (D-NY) is quite comprehensive, which should be no surprise given her history with the issue. That said, the organization of the written plan is a bit of a challenge, and one is encouraged to read the entire plan rather than the three-page executive summary at the beginning, which does not exactly track with the plan.
At her campaign site, you can see a summary of Senator Clinton’s healthcare plan, or you can download the entire 16-page plan. The overwhelming element to this plan is insurance reform and she aims to increase the number of insured through various mechanisms that include new insurance schemes and practices that will expand coverage, lower premiums and to increase the ability of the insured to stay that way.
It is in the last section of the plan (not the executive summary) where the five categories being addressed in this review are found under the heading “Fiscal Responsibility that Honors our Priorities” each is addressed with brevity. However, she is also laying claim with this section to $4 billion in savings as a result of their implementation:
1. Importation of Drugs - While not mentioned in the body of the plan, allowing reimportation is figured into the balance sheet at the end of the plan that computes the $4 billion savings.
2. Medicare Part D Reform - She states that she favors applying purchasing leverage to reduce prescription drug costs by allowing Medicare to negotiate lower drug prices. also part of the $4 billion savings.
3. Pharmaceutical Marketing Restrictions - There is no specific mention of what she means by this, but the plan states that she should provide “more oversight over pharmaceutical companies’ financial relationships with providers.” There is no mention of direct-to-consumer advertising or data marketing practices, but seems to focus solely on the relationship with prescribers. This is also part of the $4 billion savings.
4. Follow-on-Biologic Regulation - She states that part of the savings that will be realized in her plan will come from creating a pathway for “biogeneric” drug competition but fails to detail what that pathway would look like. Her choice of the term “biogenerics” regarded by many in industry as a misnomer since biologics cannot be exactly copied and therefore cannot be generics in the same sense of a chemical compound is open to interpretation, but may signal an unwillingness to embrace that position.
5. Generic Promotion - Again with no specificity, the plan states that an object of the plan is “removing barriers to generic competition” and that is the sum of dedicated effort to that subject. Whether this means an erosion of intellectual property or other means of removing barriers is simply not clear.
Analysis: If each of the elements of this plan listed above were enacted, the future growth of pharmaceutical sales would likely be impacted. As the IMS report released last week noted, one of the reasons IMS was projecting lower growth for pharmaceutical sales was the increase in generics and the attacks on intellectual property. The use of the term “biogeneric” along with the anticipation of savings to the government may mean that she is interested in a pathway that offers the least protection for intellectual property of biologics, which some may see as having a chilling effect on innovation in that industry. The plan assumes a $4 billion savings from enacting reforms 1-5 above, but without specifics addressing each of these there is no way to assess the accuracy of that claim. Despite the fact that the plan is comprehensive in scope, it is very short on details when the future of the pharmaceutical and biologic markets are concerned.
Next on deck - Senator Christopher Dodd (D-CONN). but beware, it is slim pickins.
Eye On FDA is a regular contributor to BioHealth Investor
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Monday’s Top Biotech & Medical Stocks
by H.S. Ayoub
BioHealth Investor
Biotechnology
TERCICA INC [TRCA] +14.94%
ENTREMED INC [ENMD] +13.53%
ADVANCED LIFE SCIENC [ADLS] +9.09%
XTL BIOPHARMACEUTICA [XTLB] +8.95%
NORTHWEST BIOTH NEW [NWBO.OB] +7.41%
Diagnostic Substances
EPICEPT CORPORATION [EPCT] +12.24%
RESPONSE GENETICS, I [RGDX] +6.62%
ASPENBIO PHARMA INC [APPY] +2.86%
MERIDIAN BIOSCIENC [VIVO] +1.36%
NYMOX PHARM CORP [NYMX] +0.53%
Drug Delivery
INSITE VISION INC [ISV] +8.11%
ACURA PHARMACEUTICAL [ACUR.OB] +7.38%
QUIGLEY CORP THE [QGLY] +2.74%
BENTLEY PHARMACEUTIC [BNT] +0.98%
ALKERMES INC [ALKS] +0.78%
Drug Manufacturers
UNITED THERAPEUTIC [UTHR] +5.32%
DUSA PHARM INC [DUSA] +4.83%
UNIGENE LABS INC [UGNE.OB] +4.71%
NEUROCHEM INC [NRMX] +4.00%
PLANET TECHS INC [PLNT.OB] +3.77%
Drug Related Products
IMAGENETIX INC [IAGX.OB] +2.54%
MEDICAL NUTRITN USA [MDNU] +2.50%
SALIX PHARM DEL [SLXP] +1.33%
PERRIGO COMPANY [PRGO] +1.04%
ARGAN INC [AGX] +0.49%
Generic Drugs
HELICOS BIOSCIENCES [HLCS] +6.60%
LOTUS PHARMACEUTICAL [LTUS.OB] +3.64%
WATSON PHARMACEUTCLS [WPI] +0.67%
Medical Appliances & Equipment
SPO MEDICAL INC [SPOM.OB] +14.29%
REFLECT SCIENTIFIC [RSCF.OB] +11.36%
ZYNEX MEDICAL HLDGS [ZYNX.OB] +10.45%
EXACTECH INC [EXAC] +10.21%
SRI/SURGICAL EXPRE [STRC] +6.50%
Medical Instruments & Supplies
BIOSPHERE MEDICAL [BSMD] +20.56%
STEN CORPORATION [STEN] +11.82%
[NSPH] +9.07%
XTENT INC [XTNT] +4.66%
CARDIOTECH INTL [CTE] 0.00%
Medical Laboratories & Research
ERESEARCHTECHNOLOG [ERES] +13.32%
PREMD INC [PME] +8.43%
MEDTOX SCIENTFIC INC [MTOX] +6.62%
AETERNA ZENTARIS [AEZS] +4.28%
ENZO BIOCHEM INC [ENZ] +1.42%
- Thursday’s Top Biotech & Medical Stocks
- Wednesday’s Top Biotech & Medical Stocks
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Follow-on Biologics Revisited: Who’s on First?
by Greg B. Scott
ChinaBio Today
On September 27, President Bush signed into law H.R. 3580, the Food and Drug Administration Amendments Act of 2007, which, according to the FDA, “represents a very significant addition to FDA authority” and provides “significant benefits for those who develop medical products, and for those who use them.” But what was most significant to the biotech industry was not the terms of the Act, but what was left out – the provision that would have given the FDA the authority to approve generic biotech drugs, or “follow-on biologics” (FOBs).
With no major health care bills expected to move through Congress for at least a year or two, FOBs may be dead until 2010. But, as Yogi Berra put it so succinctly…
“It ain’t over ‘til it’s over.”
On June 26, Senators Kennedy, Clinton, Hatch, Enzi et al introduced the bi-partisan Biologics Price Competition and Innovation Act, S1695, which provides a path for FDA approval of FOBs while (hopefully) continuing to stimulate new drug development. And on June 27, it was passed by the Senate Health, Education, Labor and Pensions Committee. So while it is still very early in the legislative process, S1695 is very much alive.
But not uncontested. U.S. sales of biotech drugs grew nearly 20 percent last year to over $40 billion. This is plenty of incentive for the players to draw battle lines and embark on an all-out war to win their fair share of the spoils.
“Déjà vu all over again.”
Advocates of S1695 believe the bill will significantly reduce the high cost of biologic drugs, thereby making them more widely available, reducing overall healthcare costs, and improving the general health of the U.S. population. It could also make generic drug manufacturers like Dr. Reddy’s, Barr, Ranbaxy, and Teva very rich, as they could now enter a very high stakes game previously unavailable to them.
Detractors believe that there are significant safety issues, due in great part to the well-known variability of biologics in manufacture. They also believe it will disincentivize the industry to invest in the most costly class of drugs to develop and manufacture. This will cause the pipeline of new biologics to dry up, and negatively impact the long term health of the U.S. population. Patient safety is obviously concern #1. But is the industry’s concern centered on safety or the lost profits that the big biotech makers like Genentech, Amgen, Biogen-Idec and others might face?
“When you come to a fork in the road, take it.”
I will leave it to the reader to determine which side of the fence they personally land on. Nevertheless, whether it’s the result of S1695 or some future bill, legal or regulatory action, the industry must eventually grapple with the complex issues of follow-on biologics: how to ensure they are safe and broadly available at a reasonable cost without negatively impacting the incentive for the industry to invest in a vital technology that is generating many of our most effective therapeutics.
If you would like to learn more about S1695 or read it in its entirety, please go www.BioBusinessNews.com/bonus.
ChinaBio Today is a regular contributor to BioHealth Investor
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Networks Fuel Cancer Fright with Food Terror
by Paul Detrick
Business & Media Institute
CNN and CBS scare with ‘frightening’ results of study finding processed meat to cause cancer.
CBS’s “Evening News” October 31 and CNN’s “American Morning” November 1 decided to enjoy some of the Halloween spirit by scaring viewers with a “landmark” study finding consumption of processed meat could increase the risk of colon cancer.
CBS anchor Katie Couric made up her mind after the “frightening” news saying, “No more bacon for me,” and CNN’s Kiran Chetry found the news of the findings “very shocking” and noted that “I’m in real trouble here” because of her own eating habits.
Chetry went even further, “I guess what is so astounding is if they can extrapolate … that it really does cause that much of a jump in risk it should come with a warning label you know just like cigarettes or alcohol does. That’s what seems to be so surprising.”
She later warned her co-host John Roberts to ditch the bacon and to “get rid of it, just hard boiled eggs or Raisin Bran.”
Medical Correspondent for CNN Elizabeth Cohen at least allowed business its say noting, “The meat industry calls this, ‘Extreme, unfounded and irresponsible.’”
Cohen also said that it was possible to find experts not affiliated with the meat industry that would say, “not to eat processed meats at all is going a little overboard.”
“This report is suggesting moderation, not total deprivation,” added Dr. John LaPook of CBS.
The November 1 USA Today story about the report agreed. It featured Karen Collins, a cancer institute nutrition adviser who urged some caution, but not a complete ban on processed meats. “This is a wake-up call for people who eat hot dogs or pepperoni pizza regularly. They need to be looking for other alternatives. But you can still occasionally have a hot dog,” she said.
That article, written by Nanci Hellmich, also had a few more business viewpoints to share on the study.
In response to the study, Mary Young of the National Cattlemen’s Beef Association said the group had “engaged scientists to review the scientific literature on the topic, and they concluded there is no evidence red meat causes cancer.”
Ceci Snyder, a registered dietitian with the National Pork Board, said, “The U.S. Dietary Guidelines include meat and processed meat, and those guidelines are based on a review of the scientific evidence.”
The Center for Consumer Freedom said this was just part of a campaign against food. “Bottom line: Anything that tastes good must be bad,” the group said, pointing out that the researchers, “downplayed, the fact that traditional ‘health’ foods like fruits and [vegetables] don’t necessarily prevent cancer as previously believed.”
“Menu warning labels and other food cop regulations aren’t bolstered by actual empirical evidence, but by speculation and focus groups,” said the article.
Business & Media Institute is a regular contributor to BioHealth Investor
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MRI to Lead Growth in Medical-Imaging Market
by Sara Calabro
Med Tech Sentinel
The U.S. medical-imaging market — including ultrasound, magnetic resonance imaging (MRI), radiography and mammography, and computed tomography (CT) — will be worth an estimated $11.4 billion by 2012, according to a new report by BCC Research, Medical Imaging: Equipment and Related Products.
CT currently accounts for the largest share of the market — worth an estimated $2.3 billion in 2007 — and is predicted to top $3.2 billion by 2012.
But MRI scanners, now with the second-most market share, are the fastest-growing segment, with a projected CAGR of 9.8 percent. Currently valued at over $1.8 billion, the MRI scanner market is expected to exceed $2.8 billion in 2012.
The third-largest segment, ultrasound equipment, is currently valued at $1.6 billion and is expected to grow with a CAGR of 6.9 percent to $2.3 billion in 2012.
Radiography and mammography equipment also is expected to experience significant growth, from a current value of $1.3 billion in 2007 to nearly $2 billion in 2012.
And positron emission tomography (PET) scanners, including combination PET/CT machines, are expected to grow from $669.8 million this year to $991.0 million in 2012.
On Tuesday, two leading diagnostic-imaging companies — E-Z-EM (EZEM), of Lake Success, NY, and Bracco Diagnostics, the U.S. subsidiary of Milan, Italy-based Bracco Imaging — announced plans to merge. Bracco will acquire all of the outstanding shares of E-Z-EM, in a cash transaction valued at $241 million.
E-Z-EM manufacturers contrast agents for gastrointestinal radiology. Products include VoLumen, a patent-pending, low-density barium sulfate suspension for use as an oral contrast in multi-detector CT and PET/CT studies. The company also makes Empower, the first family of CT injectors on the market with patented EDA technology for detecting contrast extravasation.
Med Tech Sentinel is a regular contributor to BioHealth Investor
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