Category Archives: Novo

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

 

 

 

 

 

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

Teva’s biologics entry into the generic and branded pharma market will cause further disruption


We have an interesting ideas for small cap biotech pharma
Generic biologicals. All the biologicals ( amgen, J&j) 2011 injectbiles.

Generic Company Teva

Barr and hospira make the generic biologicals .

Teva have been  diversifying away from being a generic company  to more of a branded as they  they have a branded drug copaxon. ~ MS drug .

Big Question.: Can the FDA approve generic biologicals? There is no process for doing.

Remember in the new Buy and bill model  step (1) doctor buy and bills patient/ insurance company. (only for onjectibles) the pharma companies ARE NOT supposed to promote the spread. Before the health care legislation it used to be paid on awp. (average wholesale price) not it’s reimburseable on asp (average selling price) they have changed the reimbursement rate to average selling price + 6% for doctors. Injectibles (only doctors)

Specialty pharmacies (caremark) are the new growth market. Certain ailments require specialty drugs!

More ideas and research at www.57thstventures.com

Japanese Drug Market top 3 in Market Share is changing


Japanese Drug market $100 billion is second in the world behind the US. Yet the top 3 in market share make up only on 17.7% of the market! There’s a huge opportunity for Merck, Roche and Astellas to make significant inroads into the lucrative Japanese Drug Market!

#1) Increase G&A marketing expenses to take advantage of “direct to consumer” that Japanese consumers are embracing! Promo activities like newspaper advertising and sales reps calling on doctors

#2) increase pipeline by looking to buy or have joint venture with Eisai or Mitshubishi Tanabe

#3) Create more social awareness to overcome society stigmas thru social media campaigns

Search our blog for more or read more research exerpts at 57th St Ventures

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

Novo’s Degludec Insulin as Effective as Sanofi’s Lantus With Fewer Doses


Nova’s Degludec shows promise in 10,000 person trial

Novo Nordisk A/S’s experimental insulin degludec, taken three times a week to treat diabetes, was as effective as Sanofi-Aventis SA’s once-daily Lantus in a mid-stage clinical trial.

Degludec lowered blood sugar levels as much as Lantus, Bagsvaerd, Denmark-based Novo said in a statement today at the American Diabetes Association meeting in Orlando, Florida. About one in four patients, or 23 percent, reported episodes of too low blood sugar, similar to Lantus, Novo said, citing the study by researchers including Bernard Zinman of Mount Sinai Hospital in Toronto. That condition, called hypoglycemia, can cause confusion, fainting and death.

The convenience of taking degludec three times a week will win over diabetics, said Alan Moses, Novo’s chief medical officer. Sanofi’s product leads the market, with sales last year of 3.08 billion euros ($3.8 billion). The combined revenue from Novo’s engineered insulins, Levemir, NovoRapid and NovoMix, was 21.5 billion kroner ($3.55 billion) in 2009.

“What we hear from patients is that they’re craving anything that will lower the frequency of their injections,” Moses said in a telephone interview.

Taken daily, degludec was less effective than Lantus, Novo said. Fewer than one in 10 had confirmed hypoglycemic episodes.

In patients taking degludec three times a week in the 16- week trial, the percentage of red blood cells to which sugar had attached, a measure of the illness’ severity, fell by 1.5 points, Novo Nordisk said. The same decline was reported for patients on Lantus, the Danish drugmaker said. Taken daily, degludec reduced blood sugar levels by 1.3 percentage points.

Daily Shots

Some diabetics must take as many as four shots a day: a so- called basal insulin, which maintains a steady level of the hormone throughout the day, and three shots to coincide with mealtimes. Diabetics don’t produce enough insulin to absorb the sugar into which food is broken down. It collects in the blood and may cause kidney failure, heart problems and blindness.

Novo Nordisk last year began the final phase of testing degludec and a second experimental insulin, degludec plus, after initial results were positive. The trials, in which about 10,000 people are participating, are the largest ever for the Danish drugmaker, whose growth has been driven by engineered insulins.

Another experimental insulin, which combines degludec with a mealtime insulin, lowered the majority of diabetics’ blood sugar to recommended levels as effectively as Lantus without major episodes of hypoglycemia, Novo said. One-hundred and nineteen people participated in the 16-week, early-phase trial.