Category Archives: ZELTIA

Big Pharma and Biotech companies continue to cut marketing spending in US


We’ve been covering this topic for a while now.  Correctly I may add (see earlier post)     

https://57thstresearch.wordpress.com/2011/09/16/e-detailing-and-cloud-ipad-are-changing-in-pharma-generics-and-biologics-massive-sales-reps-to-be-layed-off/

AstraZeneca is the latest large pharma company  to report disappointing financials including  net profit  (- 8.3%) and top line revenue (-400 million) from last year.  The company is now outsourcing research and using more digital technologies to reduce overall head count and fixed costs.

In a very ominous sign AstraZeneca has “outsourced” research groups in North America and Eastern Europe with virtual groups at academic institutions and small biotechs.  The reasons the companies cited are “lower cost base” and access to best academic minds available (Yeah right))!

We expect mergers and acquisitions to pick up in the large cap marketplace as expiring patents, frugal insurers, generic competition and a dearth of new medicine has transformed these large innovate companies into “one trick” ponies.

The traditional pharma reps with fleets of new cars  full of doctor samples is no longer needed.  Companies are now use digital marketing tools complete with online avatar of sales presentation and IPAD’s to seamlessly integrate payments from insurers.  Companies that haven’t laid off enough sales teams are trying to position the sales teams as “trusted advocates”. The trusted advocate role is not long term as most doctors won’t see the value and companies will have a hard time not laying off higher paid employees for telemarketers,  low cost replacements or contract sales personnel.

 

Stay tuned for more and catch more indepth research at http://www.57thstventures.com

Generic Company Teva

 

 

 

 

 

Infotech companies that specialize in trimming health care costs are great picks in 2012


Despite all the talk about trimming health care costs, the reality is that only a fraction of doctors today use money saving Infotech.

Question : What is Infotech?

Answer:  Companies that provide new data systems that link patient records, testing labs, pharmacies, and insurers are HITTING the market.

In 2011 a record $410 Million in health care infotech.  

Startup companies to watch include:

Watermark– has an attachment that a diabetic can stick in your Iphone slot and receive sugar levels from “the cloud”. A doctor is alerted if your levels get too high.

Athena – prints a bar code onto a blood vial to replace the possible inaccuracies that a technician may cause. The bar code is then scanned and electronically sent to the testing lab. The results are then provided to the doctors A/R and to the insurer. Huge savings are realized in labor and errors.

The strategy of these infotech companies to to focus on the chronic disease market that affects 90% of the U.S. population.

Investors should look at this market because only 1% of today’s doctors have “closed loop systems” so the penetration % will grow especially with the new health care laws that favor EHR (Electronic Healt
h Records)

more at www.57thstventures.com

MELA is finally granted an approval letter by FDA? Now what?


MELA finally got an approval letter from the FDA.  Does this mean that the Cancer Diagnostic MELAFIND device maker will finally be able to go to market? 

Shares surged for the  medical device maker gained on newsfor its MelaFind device used to diagnose melanoma, the deadliest form of skin cancer.

“The Company said it will work with the agency to finalize the physician and patient labeling, package insert, user’s guide, training program and clinical protocol for a post-approval study in order to obtain final approval.”

We say yes but until 2Q 2012.  Why you say? Because the FDA will not fast track the stock

Competitors include Siemens and GE    Sign up now for all the new www.57thstventures.com

Sorrell vs. IMF Health goes deep inside business of pharma data mining techniques


There is a landmark case that speaks to the hot button issue of PRIVACY.

The case challenges a Vermont Law that letting doctors decide whether their names can be sold 

to pharma companies for marketing purposes.

Here’s how it works currently (Step 1)  Pharmacists sell the information to data mining companies , which then sell

data and analysis (i.e. which customers would be great prospective prospects for “detailing”) to pharma companies WITH

PATIENT NAMES removed or encrypted.  That data fuels drug companies CRM efforts using companies such as ZS Associates

to do statistical regression studies that present data on prospects, territories profiles etc.

The outcome is purely based on Free Speech and is likely to be won by the 3 data companies (IMF Health, SDI Health and Source Analytics).

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Technology Investments are changing clinical studies in Pharma and Biotech


Changing Technology is innovating drugmakers supply chain

Health information access is changing the ways drugmakers develop medicines and communicate with doctors, insurers and patients. Better info from patient records is helping companies design more cost-effective clinical trials and tailor marketing materials to the people who most need them. For example, mobile phone software can help patients find clinical trials for cancer or track blood-sugar levels.

Large Investments by drugmakers are falling behind non- pharmaceutical companies, including  General Electric Co., Telus Corp., Canada’s third-and International Business Machines Corp., which have committed to spending at least $20 billion on health-related information services. Pharmaceutical companies have invested “a small fraction of that but over the next decade, monitoring patient care and proving results will be an increasing part of their business.

Applications created for Apple Inc.’s iPhone include a German language DiabetesMapp, which helps patients map specialists nearby, by A Abbott Laboratories; Merck’s Vree for diabetes education and tracking of blood glucose, nutrition, and activity; and Novartis’s VaxTrak to keep records of vaccinations.

Stay tuned for more updates at www.57thstventures.com

Celgene and Sanofi-Aventis announce acquisitions in cancer market!


Oncology is where the growth is and Celgene

Celgene and Sanofi-Aventis on Wednesday each announced acquisitions of companies that make cancer drugs, highlighting the field as a key growth area in the years ahead.

The larger of the two deals was Celgene’s cash-and-shares acquisition of Abraxis BioSicence, valued at $2.9 billion.

Terms call for Summit, N.J.-based Celgene to give each holder of Abraxis $58 a share in cash, 0.2617 Celgene shares as well as, unusually, one tradeable contingent value right tied to future regulatory milestones and commercial royalties.

Based on Tuesday’s prices, the deal values each Abraxis share at $71.93 a share, compared to its close of $61.31.

Los Angeles-headquartered Abraxis makes Abraxane, used to treat breast cancer in patients where chemotherapy didn’t work. The drug also is approved for use in rare cases of stage IIB-IV melanoma and pancreatic cancer, and the drug may be able to treat tumor malignancies such as non-small cell lung and pancreatic cancer. Abraxis has developed what it calls nab-driven chemotherapy technology, which uses nanoparticles to deliver chemotherapeutics to the tumor.

The contingent value right encompasses a pool of up to $250 million depending on U.S. approval for non-small cell lung cancer, $300 million for approval for pancreatic cancer, another $100 million if the pancreatic cancer use is approved by April 1, 2013 as well as other royalty payments.

The other oncology deal had the French firm Sanofi-Aventis paying $75 million upfront and up to $560 million for San Diego-based TargeGen, a privately held biopharmaceutical which makes drugs to treat leukemia, lymphoma and other blood disorders.

TargeGen has completed Phase I/II studies of TG 101348, with additional studies due to start in the second half of 2010.

Sanofi shares climbed 1.1% in Paris.

Small Cap Health Care stock pick – ZEL:SM Zeltia SA developing Yondelis for use in combination with Johnson & Johnson’s (JNJ.N)


Zeltia has been developing Yondelis for use in combination with Johnson & Johnson’s (JNJ.N) Doxil for the treatment of ovarian cancer, but has so far failed to win a green light for the medicine in the United States.

6 months ago Madrid-based Zeltia SA agreed to pay for any patient who needs more than five cycles of Yondelis for soft- tissue sarcoma. This will allow broader use and the european regulators are taking notice.

Latest News
Stock Price  3.580     Open 3.525
Volume 877,523     High 3.580  Low 3.470
52-Wk High (07/06/09)5.670   52-Wk Low (07/16/09)2.555 1-Yr
FUNDAMENTALS
Shares (Millions)222.205 Market Cap (Millions)795.494 Earnings-0.116 Price/EarningsN.A. Relative P/EN.A. ROE-57.193
We are recommending the loss-making pharmaceutical firm’s Yondelis drug for use in the treatment of ovarian cancer.

Zeltia Chairman Jose Maria Fernandez Sousa-Faro reiterated forecasts that sales from Yondelis could be 300 million euros ($440.5 million) a year in Europe and that the company could break even or make a small profit by the end of 2010. (WE KNOW IT’S GONNA HAPPEN)

Zeltia expected other countries to follow the lead shown by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

“It’s highly probable that within a few months the only country which hasn’t approved it will be the United States,” said Luis Mora, managing director for Zeltia’s PharmaMar biotech unit. (CMON FDA )

J&J broad distribution would make Yondelis a $1B drug in 3 years

Order the research report at www.57thstventures.com

The news is a fillip for the European biotechnology sector, which has lagged well behind the United States in getting new drugs to market.

The European decision contrasts with the verdict of the U.S. Food and Drug Administration, whose experts were concerned that risks of heart and liver toxicity outweighed the limited ability of Yondelis to keep disease in check.

Yondelis, known chemically as trabectedin, is already sold in Europe as a treatment for soft tissue sarcoma, a relatively rare disease affecting soft tissues such as muscle, fat and tissue around joints.

The medicine is unusual in that it is a synthetic version of a compound isolated from a type of sea squirt, a tubular marine animal. It works by binding to the DNA of cancer cells and blocking their ability to multiply.

J&J (JNJ) and Novartis (NOVN) beat estimates but Wall Street not impressed. Why?


J&J and the recall at McNeil have hurt the stock’s rally. J&J is not a “growth stock” in spite of  having a very promising pipeline referring if J&J wins approvals for important new products, including two potential blockbusters: Xarelto to prevent blood clots and telaprevir for hepatitis C.

Novartis will keep rolling … read on www.57thstventures.com

* J&J Q1 EPS ex-items $1.29 vs $1.27 forecast

* Trims 2010 forecast, absorbs healthcare reform cost

* Novartis beats with flu drug sales, keeps 2010 view inline!!

Johnson & Johnson and Novartis Holding reported better-than-expected quarterly earnings, but the results did not suggest accelerating growth for the drugmakers.

J&J saw strong sales for “medical devices” but it’s “prescription drug sales disappointed investors “for the fourth or fifth quarter in a row,”

Sales of medical devices jumped 12.5 percent to $6.23 billion in the quarter.

The J&J  earned $4.53 billion, or $1.62 per share, compared with $3.51 billion, or $1.26 per share, in the year-earlier period.

Analysts on average had expected $1.27 per share

J&J trimmed its full-year profit forecast to between $4.80 and $4.90 per share, excluding items, from its earlier view of $4.85 to $4.95.

The company said the adjustment was due to changes in foreign currency rates, and incorporates initial costs of recently enacted U.S. healthcare reforms that require drugmakers to grant bigger price rebates to Medicaid patients. (?????)  57thstventures.com sees big headwinds ahead especially with the recent McNeil recall

Novartis reported first-quarter earnings of $1.29 per share, beating the average estimate of $1.11. It cited strong sales of new blood pressure drugs Exforge and Tekturna, and cancer drugs Zometa and Femara.

Novartis also said it plans to eliminate 383 full-time U.S. jobs, primarily at its U.S. headquarters, to streamline its operations and prepare for generic competition for its blockbuster Diovan blood-pressure medicine.

Investors shrugged off the results. Shares in J&J closed down just 0.1 percent to $65.99, while Novartis’ U.S.-listed shares rose 0.1 percent to $53.41.

J&J CFO SEES END OF TOPAMAX DRAG

J&J is also grappling with generic competition that helped fuel a 2.5 percent decline in global drug sales to $5.64 billion during the quarter.

J&J’s global company revenue rose 4 percent to $15.63 billion, in line with Wall Street forecasts, but would have been nearly unchanged if not for foreign exchange factors.