The transaction is estimated to be work $345M.
Marketed Products by Ortho Dermatologics Division:
- Retin-A micro which is the tretinoin gel microsphere) 0.04%/0.1%
- Renova (tretinoin cream) 0.02%
- Biafine
- Ertaczo
- Grifulvin V
A pharmaceutical news and commentary post
Saturday, July 16, 2011
Janssen has signed definitive agreement with Valeant Pharmaceuticals
Janssen Pharmaceuticals (J&J) announces that it has signed a definitive agreement with Valeant Pharmaceuticals international to divest its assessts of its Ortho Dermatologics Division in the US.
The transaction is estimated to be work $345M.
Marketed Products by Ortho Dermatologics Division:
The transaction is estimated to be work $345M.
Marketed Products by Ortho Dermatologics Division:
Friday, July 15, 2011
Mylan is to release its second quarter earnings on July 27
Knock knock knock..earning season is in full swing this time..
Mylan is set to release its earning of the second quarter on July 27, 2011 before the market opens.
The company will hold a conference call and live webcast on the same day at 10:30 am Eastern Time.
The conference call can be accessed as followed:
Mylan is set to release its earning of the second quarter on July 27, 2011 before the market opens.
The company will hold a conference call and live webcast on the same day at 10:30 am Eastern Time.
The conference call can be accessed as followed:
Teva Pharmaceuticals completed acquisition of Taiyo
Don't you love it when I posted the completion of two acquisitions within the same day?
Teva Pharmaceuticals announced that it has completed the acquisition of Taiyo Pharmaceutical for $934M in cash. The news was previously announced in May.
Taiyo is the third largest generic manufacturer in Japan and had the annual sales of
Teva Pharmaceuticals announced that it has completed the acquisition of Taiyo Pharmaceutical for $934M in cash. The news was previously announced in May.
Taiyo is the third largest generic manufacturer in Japan and had the annual sales of
Cilag completed Over the counter brands of JB Chemical and Pharmaceuticals limited
Cilag Gmbh of Johnson and Johnson announced that it has completed the acquisition of the Over-the-counter brands of JB Chemicals and Pharmaceuticals limited with an approximately $245M US dollars.
Details of the transaction is as follow:
Details of the transaction is as follow:
- JB Chemical & Pharmaceutical is to sell its Russia/CIS OTC Business to Cilag (Johnson and Johnson subsidiary) for INR 9,385M (which is approximately 206M US dollars, I wish they just wrote 9.385B instead of 9 thousand something million).
- In addition, the company has also agreed to sale the worldwide rights and registration of its 3 OTC brands to Cilag for an additional INR 60.67M (which is approximately 1.3M). The three OTC brands are: Doktor Mom, Rinza, and Fitovit.
- Johnson & Johnson has also signed a contract with JBCPL in Russia to purchase its OTC inventory for an additional $47M
- This totaled to approximately $260M as reported by JNJ.
Cubist posted a net loss in its second quarter 2011
Cubist released the results from its second quarter 2011 with a net loss of $20.6M, a decline of almost $50M compared to a net income of $28.1M from the same quarter of last year.
The company had an increase in revenues in the second quarter when compared to the same quarter of last year (178.8M vs 168.5M).
Disappointing? yes but at the same the company has only one product on the market. Antibiotic is great because it can treat a lot of different types of infection but many physicians even though embrace new antibiotic developments and approvals might not be willing to use the new drug immediately. In fact, they are not first line because they are good. They are often reserved when the bugs are resistant to the long marketed medications.
The company has one produt on the market which is Cubicin or daptomycin. It has recently signed an exclusive two-year co-promotion agreement with Optimer Pharmaceutical to market Dificid (fidamoxicin tablets in the US. Dificid has been approved for the treatment of Clostridium difficile-associated diarrhea.
As of June 30, 2011, the company had $1B in cash, cash equivalents and investments.
The company held a conference call on Thursday July 14, 2011 at 5:00 PM eastern time. The replay of the phone conference is available now available and can be accessed through:
The company had an increase in revenues in the second quarter when compared to the same quarter of last year (178.8M vs 168.5M).
Disappointing? yes but at the same the company has only one product on the market. Antibiotic is great because it can treat a lot of different types of infection but many physicians even though embrace new antibiotic developments and approvals might not be willing to use the new drug immediately. In fact, they are not first line because they are good. They are often reserved when the bugs are resistant to the long marketed medications.
The company has one produt on the market which is Cubicin or daptomycin. It has recently signed an exclusive two-year co-promotion agreement with Optimer Pharmaceutical to market Dificid (fidamoxicin tablets in the US. Dificid has been approved for the treatment of Clostridium difficile-associated diarrhea.
As of June 30, 2011, the company had $1B in cash, cash equivalents and investments.
The company held a conference call on Thursday July 14, 2011 at 5:00 PM eastern time. The replay of the phone conference is available now available and can be accessed through:
- calling from international territories: 1-201-612-7415
- calling from Canada or the US: 1-877-660-6853
- Replay passcode:
- Account #: 351
- Conference ID #: 369326
- The replay of the webcast is available at the company investor relation page
- CXA-201: combination of CXA-101 and tazobactam intravenous administration. It's currently being studied in phsae II for complicated urinary tract infection, complicated intra abdominal infection. It's currently in phase I for nosocomial pneumonia. Cubist has worldwide rights for the company except for selected Asia-Pacific and Middle East Territories. The compound was acquired under the license from Astellas Pharma.
- CB-183-315: it is an oral novel lipopeptide developed for the treatment of clostridium difficile associated diarrhea (CDAD). It's in phase II
Thursday, July 14, 2011
Johnson and Johnson released its earnings of 2nd quarter 2011
The company will simultaneously host a webcast on the same day. To access the webcast please click here
Rxi Pharmaceuticals acquired patent rights to NeuVax
Rxi Pharmcaceuticals announced that acquired patent rights covering the use of NeuVax used in combination with trastuzumab and its use in low-to-moderate HER2 positive breast cancer patients who are not eligible for Herceptin therapy. The patents licensed from the Henry M Jackson Foundation and the Advancement of Military Medicine.
The company plans to initiate the phase III trial under the Special Protocol Assessment granted by the the US FDA in early-stage, node-positive breast cancer with low to intermediate HER2 Expression in the first half of 2012.
NeuVax is an E75 peptide derived from HER2 combined with the immune adjuvant granulocyate macrophage colony stimulating factor. NeuVax can be given intradermally once a month for six months and a booster injection every six months.
The company plans to initiate the phase III trial under the Special Protocol Assessment granted by the the US FDA in early-stage, node-positive breast cancer with low to intermediate HER2 Expression in the first half of 2012.
NeuVax is an E75 peptide derived from HER2 combined with the immune adjuvant granulocyate macrophage colony stimulating factor. NeuVax can be given intradermally once a month for six months and a booster injection every six months.
Array and Aslan signed agreement for ARRY-543
Array BioPharma announced that it has signed a license agreement with Aslan Pharmaceuticals to develop HER2/ EGFR Inhibitor ARRY-543 which is being evaluated as potential treatment for certain kinds of cancer..
The compound is currently being evaluated in the phase 2 clinical development for solid tumors.
Under the terms of the agreement, Aslan will fund and develop ARRY-543 globally through the proof of concept. The company will initially develop the compound as potential treatment in gastric cancer through the clinical development program conducted in Asia. Aslan will identify a global partner who will work with Aslan to complete the phase 3 development and commercialization once ARRY-542 passes the proof of concept trial.
Array will be eligible to receive payments from Aslan under the terms of the transaction.
Both companies are currently working to license a second undisclosed compound.
ARRY-543 is a novel, selective and oral HER2/EGFR inhibitor. It works by inhibiting the growth of blood vessels which are often necessary for growth of cancer cells.
The compound is currently being evaluated in the phase 2 clinical development for solid tumors.
Under the terms of the agreement, Aslan will fund and develop ARRY-543 globally through the proof of concept. The company will initially develop the compound as potential treatment in gastric cancer through the clinical development program conducted in Asia. Aslan will identify a global partner who will work with Aslan to complete the phase 3 development and commercialization once ARRY-542 passes the proof of concept trial.
Array will be eligible to receive payments from Aslan under the terms of the transaction.
Both companies are currently working to license a second undisclosed compound.
ARRY-543 is a novel, selective and oral HER2/EGFR inhibitor. It works by inhibiting the growth of blood vessels which are often necessary for growth of cancer cells.
Transcept announced disappointing news to investors
Transcept announced a disappointing news....
The company said that the FDA expressed concerns about the safety profile surrounding Intermezzo which is a zolpidem tartrate sublingual tablet filed for the treatment of insomnia in patients who often experienced awakening in the middle of the night and had trouble getting back to sleep.
The company's stock hit its 52-week trending low and settled at 4.94 when the market closed. It posted an approximately 42.5% drop in value in a single day. This percentage is even higher than when Salix announced that it anticipated that the FDA would not approve Xixafan 550 mg tablet.
Transcept resubmitted the NDA in Jan 2011 and now anticipated the complete response letter for its resubmission.
The company plans to announce additional details when it receives the complete response from the FDA to interest parties.
The company said that the FDA expressed concerns about the safety profile surrounding Intermezzo which is a zolpidem tartrate sublingual tablet filed for the treatment of insomnia in patients who often experienced awakening in the middle of the night and had trouble getting back to sleep.
The company's stock hit its 52-week trending low and settled at 4.94 when the market closed. It posted an approximately 42.5% drop in value in a single day. This percentage is even higher than when Salix announced that it anticipated that the FDA would not approve Xixafan 550 mg tablet.
Transcept resubmitted the NDA in Jan 2011 and now anticipated the complete response letter for its resubmission.
The company plans to announce additional details when it receives the complete response from the FDA to interest parties.
Agreement:
- Purdue Pharmaceuticals signed an agreement with Transcept in 2009 to commercialize Intermezzo in the US. Transcept received an upfront payment of 25M to continue the development of Intermezzo while Purdue will be responsible for the effort and costs to commercialize this product in the US. This includes sales, marketing, post-approval regulatory affairs activities and commitments as well as product manufacturing. In addition, once approved, Transcept is entitled to receive up to 30M. Once commercialized, Transcept is entitled to receive up to 90M additional milestone payment that is related to achievement of intellectual property and US net sales targets.
- If Transcept decided to co-promote Intermezzo to psychiatrist, Transcept will be entitled to receive an additional double-digit royalty in addition to what Purdue will pay it on the US net sales of Intermezzo.
Wednesday, July 13, 2011
Teva sets date for its second quarter 2011
Teva announced that it is to release the results of its second quarter 2011 on July 27, 2011.
The company will also host a conference call which will be webcast simultaneously on the same date at 8:30 ET.
To participate in the conference call:
The replay of the webcast and conference call will be available until August 3, 2011 at 11:59 PM eastern Time.
The company will also host a conference call which will be webcast simultaneously on the same date at 8:30 ET.
To participate in the conference call:
- US and Canada
- 1-877-407-0784
- International
- 1-201-689-8560
- the UK
- 00-800-224-62666
The replay of the webcast and conference call will be available until August 3, 2011 at 11:59 PM eastern Time.
- 1-877-870-5176
- 1-858-384-5517
- Conference ID: 37536
Gilead signs agreement with Indian Partners for development markets
Once in a while, Gilead issued a press release..
Gilead announced that it has expanded its global acccess program to provide accelerated access to its medicines for the treatment of HIV / AIDS.
It has signed four new licensing terms with four India-based drug manufacturers: Hetero Drugs, Matrix Lab, Ranbaxy Lab and Strides Arcolab for three drug candidates in late stage development. These contract manufacturers will play key roles in supplying products produced by Gilead in development world. In addition, Gilead has also signed a licensing agreement with the Medicines Patent Pool Foundation.
The terms of these conditions granted rights to its Indian partners and the Pool to elvitegravir which is an investigational integrase inhibitor, cobicistat which is an investigational boosting agent, and the Quad which is a combination of four Gilead HIv medicines into a once a day single tablet.
Japan Tobacco has rights to commercialize elvitegravir in Japan.
Gilead announced that it has expanded its global acccess program to provide accelerated access to its medicines for the treatment of HIV / AIDS.
It has signed four new licensing terms with four India-based drug manufacturers: Hetero Drugs, Matrix Lab, Ranbaxy Lab and Strides Arcolab for three drug candidates in late stage development. These contract manufacturers will play key roles in supplying products produced by Gilead in development world. In addition, Gilead has also signed a licensing agreement with the Medicines Patent Pool Foundation.
The terms of these conditions granted rights to its Indian partners and the Pool to elvitegravir which is an investigational integrase inhibitor, cobicistat which is an investigational boosting agent, and the Quad which is a combination of four Gilead HIv medicines into a once a day single tablet.
Japan Tobacco has rights to commercialize elvitegravir in Japan.
Arena Pharmaceuticals released the results of the phase I triral evaluating APD811
Arena Pharmaceuticals released the results of the phase I trial evaluating APD811 as potential treatment of pulmonary arterial hypertension.
The trial is a randomized, double-blind, placebo-controlled trial evaluating the safety, tolerability, and pharmacokinetics of single dose of APD811 given at 0.03 mg, 0.05 mg, 0.1 mg and 0.2 mg. The trial enrolled a total of 32 healthy volunteers who were randomized into four cohorts which had 8 participants. Each cohort comprised of two groups: APD811 and placebo group. APD811 group had 6 participants and placebo group had 2 participants.
the results showed that APD811 was rapidly absorbed into the body and had a dose-proportional pharmacokinetic exposure over tested dose range. The terminal half-life of APD811 was 20 hours.
The dose-limiting events of nausea and vomiting was 0.2 mg. The most frequent emerging adverse events related to treatment were headache, nausea, vomiting, jaw pain and flushing. In addition, higher heart rates were observed in patients taking 0.05, 0.1, and 0.2 mg of APD811. Participants in the 0.1 and 0.2 mg groups also had higher corrected QT.
This is probably not a very good news for Arena when QTc prolongation has also been observed in the phase 1 trial. The development of this medication might carry a higher than usual risk due to its adverse effect profiles.
The trial is a randomized, double-blind, placebo-controlled trial evaluating the safety, tolerability, and pharmacokinetics of single dose of APD811 given at 0.03 mg, 0.05 mg, 0.1 mg and 0.2 mg. The trial enrolled a total of 32 healthy volunteers who were randomized into four cohorts which had 8 participants. Each cohort comprised of two groups: APD811 and placebo group. APD811 group had 6 participants and placebo group had 2 participants.
the results showed that APD811 was rapidly absorbed into the body and had a dose-proportional pharmacokinetic exposure over tested dose range. The terminal half-life of APD811 was 20 hours.
The dose-limiting events of nausea and vomiting was 0.2 mg. The most frequent emerging adverse events related to treatment were headache, nausea, vomiting, jaw pain and flushing. In addition, higher heart rates were observed in patients taking 0.05, 0.1, and 0.2 mg of APD811. Participants in the 0.1 and 0.2 mg groups also had higher corrected QT.
This is probably not a very good news for Arena when QTc prolongation has also been observed in the phase 1 trial. The development of this medication might carry a higher than usual risk due to its adverse effect profiles.
Tuesday, July 12, 2011
Titan Pharmaceuticals released positive top line results of the phase III trial
Titan Pharmaceuticals announced positive top line results of the confirmatory phase III trial evaluating probuphine for the treatment of opioid dependence.
Probuphine was statistically better than placebo in then primary endpoint which was measured based on the percentages of urine samples tested negative for illicit opioid use over the 24-week
Probuphine was statistically better than placebo in then primary endpoint which was measured based on the percentages of urine samples tested negative for illicit opioid use over the 24-week
Watson and Antares signed exclusive agreement
Product transfer is quite common in the industry...
Watson and Antares announced that they have signed exclusive agreement to allow Watson to commercialize Antares' topical oxybutynin gel product in the US and Canada. The company has submitted the new drug application for oxybutynin gel product to the US FDA. The PDUFA date has been set to be December 8, 2011.
Under the terms of the agreement, Watson is required to make milestone payments based on the achievement of regulatory approval and certain sale levels. Watson will also be
Watson and Antares announced that they have signed exclusive agreement to allow Watson to commercialize Antares' topical oxybutynin gel product in the US and Canada. The company has submitted the new drug application for oxybutynin gel product to the US FDA. The PDUFA date has been set to be December 8, 2011.
Under the terms of the agreement, Watson is required to make milestone payments based on the achievement of regulatory approval and certain sale levels. Watson will also be
Novartis released positive results of the phase III trial evaluating Afinitor
Novartis announced that the phase III trial evaluating Afinitor or everlimus tablets met the study's primary endpoint which was reducing the subependymal gian cell astrocytomas tumor size in patients with tuberous sclerosis.
It was a randomized, placebo-controlled phase III EXIST-1 (Examining everolimus In a Study of TSC). The trial enrolled 117 patients in which patients were randomized into either the everolimus group or the placebo group. Thirty five percent of patient sin the everolimus group experienced 50% or greater reductions in SEGA volume compared to baseline. The difference was significant as none of patients in the placebo group experienced a 50% or more reduction in SEGA volume ( p < 0.0001).
Everolimus is an mTOR inhibitor which acts to inhibit tumor cell division, blood vessel growth and cell metabolism.
The use of everolimus in this patient population has been approved in many countries: the US, Canada, Brazil, Guatemala, the Phillipines, Columbia and Korea. It is marketed as Votubia in Switzerland. The Committee for Medicinal Products for Human Use has adopted positive opinion for the approval of everolimus in patients with tuberous sclerosis.
It was a randomized, placebo-controlled phase III EXIST-1 (Examining everolimus In a Study of TSC). The trial enrolled 117 patients in which patients were randomized into either the everolimus group or the placebo group. Thirty five percent of patient sin the everolimus group experienced 50% or greater reductions in SEGA volume compared to baseline. The difference was significant as none of patients in the placebo group experienced a 50% or more reduction in SEGA volume ( p < 0.0001).
Everolimus is an mTOR inhibitor which acts to inhibit tumor cell division, blood vessel growth and cell metabolism.
The use of everolimus in this patient population has been approved in many countries: the US, Canada, Brazil, Guatemala, the Phillipines, Columbia and Korea. It is marketed as Votubia in Switzerland. The Committee for Medicinal Products for Human Use has adopted positive opinion for the approval of everolimus in patients with tuberous sclerosis.
Monday, July 11, 2011
Valeant acquired Dermik of Sanofi
Valeant just won't stop. Continuing its acquisition pathway, Valeant Pharmaceuticals announced that it has acquired Dermik which is a unit of Sanofi specializing in providing dermatological products for $425M. Including in the acquisition is worldwide rights to Sculptra(R) Aesthetic (injectable poly-L-lactic acid) in the US and Canada. The deal also transfered Sanofi's manufacturing facility located in Laval, Canada to Valeant. The manufacturing facility currently produces approximately 70 formulations with over 200 presentations of tablets, capsules, non-sterile liquids, ointments, and creams for Sanofi and other third parties. The contract manufacturing revenues in the year of 2010 from Laval was around $240M.
The company expects to have the deal closed in 2011.
The company expects to have the deal closed in 2011.
Lilly announced results of QTc study of Bydureon
Although the ongoing litigation between Lily and Amylin is still ongoing, the company announced some positive news possibly will put the companies into better relation (or at least we hope so).
Lilly announced that the QT study showed that Bydureon (developed together with Amylin and Alkermes) met the pre-specific primary endpoint. When exenatide administered at and above therapeutic levels did not induce the prolongation of the corrected QT (QTc) interval
Lilly announced that the QT study showed that Bydureon (developed together with Amylin and Alkermes) met the pre-specific primary endpoint. When exenatide administered at and above therapeutic levels did not induce the prolongation of the corrected QT (QTc) interval
Generex released positive preliminary data of Oral-Lyn - share surged
Generex announced preliminary results of the trials evaluating Generex Oral-Lyn (TM) formulation in patients with type 1 diabetes and patients with impaired glucose tolerance.
The first trial: 084: enrolled 463 patients with type 1 diabetes.
The second trial: Prevoral trial enrolled 31 patients with obesity and impaired glucose tolerance.
The results showed that:
Generex Biotechnology is a Canadian Company headquarters in Toronto. The company is traded under GNBT. Its share value in the past 52 weeks ranged from 0.12 to 0.56. Upon releasing th e news, its share surged by 67.18% (a change of 0.088)
The first trial: 084: enrolled 463 patients with type 1 diabetes.
The second trial: Prevoral trial enrolled 31 patients with obesity and impaired glucose tolerance.
The results showed that:
- Patients taking Generex Oral-lyn had an increase in the circulating plasma insulin within the first 30 minutes of administration.
- Generex Oral-lyn did not elevate insulin level for prolong period of time (reduce incidence of low blood sugar)
- Blood glucose level was reduced by 1/3 two hours after administration and 1/4 three hours after administration
- A significant decrease in A1c level in patients with Impaired glucose tolerance when compared to placebo (-0.34 vs +0.07, p =0.03) while maintaining baseline values of A1C level in patients with type 1 diabetes
- No association between the administration of Generex Oral-lyn and serious hypoglycemia was observed.
Generex Biotechnology is a Canadian Company headquarters in Toronto. The company is traded under GNBT. Its share value in the past 52 weeks ranged from 0.12 to 0.56. Upon releasing th e news, its share surged by 67.18% (a change of 0.088)
Sunday, July 10, 2011
Sagent launches levofloxacin for injection premixed bags
Sagent pharmaceuticals announced that it has launched generic levofloxacin injection in premix bag which is the equivalent to Levaquin (J&J).
The product comes in 5% dextrose solution with three different strengths: 250 mg in 50 ml, 500 mg in 100 ml, 750 mg in 150 ml.
According to 2010 IMS data, sales of levofloxacin was approximated at $156M .
Levofloxacin is a fluoroquinolone antibacterial product that has been approved to treat a variety of infections caused by different bacterial
The product comes in 5% dextrose solution with three different strengths: 250 mg in 50 ml, 500 mg in 100 ml, 750 mg in 150 ml.
According to 2010 IMS data, sales of levofloxacin was approximated at $156M .
Levofloxacin is a fluoroquinolone antibacterial product that has been approved to treat a variety of infections caused by different bacterial
- nosocomial pneumonia
- community acquired pneumonia
- sinusitis
- chronic bronchitis
- skin and skin structure infections
- prostatitis
- urinary tract infection
- pyelnophritis
- inhalation anthrax
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