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Why Mylan thinks Teva`s shares are “toilet paper”?
In case you haven’t had time to follow the Mylan-Teva, Perrigo-Mylan saga of the past few weeks, we compiled a quick set of facts for your speed read needs: Table: Perrigo & Mylan versus Mylan & Teva:   Perrigo Mylan Teva Fast Fact World’s largest manufacturer of OTC healthcare products for the store brand market Holds the number one ranking in the U.S. generics prescription market in terms of sales Teva is the world’s largest generic medicines producer Annual Revenues (2014) $4.06 billion $7.72 billion $20.27 billion Size of their generics business $927.1 million $6.46 billion $9.8 billion Top products Tysbari®  Epi-Pen®   Copaxone®  (royalty share: 18% up to $2 billion in sales) ($1 billion) ($4.24 billion) 2013 Acquisitions DEC-2013: Elan Pharmaceuticals FEB-2013: Agila Specialties     $9.5 billion $1.75 billion     (Tax inversion)     2014 Acquisitions NOV-2014: Omega Pharma $4.5 billion JUL-2014: Abbott’s non-US generics business $5.3 billion (tax inversion)       SEPT-2014: Arixtra® rights       $300 million   2015 Acquisitions   FEB-2015: Famy Care MAR-2015: Auspex     $800 million $3.2 billion  April 2015 Perrigo & Mylan Mylan & Teva   Perrigo has rejected 3 takeover offers from Mylan. They first valued Perrigo at just under $29 billion, the next at $33 billion and the last one at $35.6 billion. Mylan rejected Teva’s unsolicited $40 billion bid for Mylan, 50% in cash and 50% in stock. Teva valued Mylan at $82/share.   If Mylan’s takeover of Perrigo fails, there is a high possibility that Teva, in its quest for growth, will eventually acquire Mylan. However, the highlight of this month long saga, has been the over 3,000 word letter Mylan’s Executive Chairman wrote when rejecting the Teva deal (Mylan internally refers to Teva stock as “toilet paper”).  Mylan’s Board answered that financially, Teva’s offer, does not even come close to qualify as a proposal worth pursuing (starting point of discussion - excess of $100 per share). Other concerns were also cited such as: Mylan having a substantial business in India, while Teva has a limited presence, and has been disparaging about India’s products and culture. In addition, should the deal come through, the massive overlapping positions would create significant antitrust concerns. On the other hand, here are some comments from the response of Mylan. Take your pick on what you think hurt the most: * “Mylan would give Teva severe indigestion”. * We believe Teva shares to be “low-quality and high-risk currency”. * Teva is offering Mylan shareholders to “take stock of a poorly performing troubled company in a combination that lacks industrial logic and is a terrible cultural fit”. * There is “persistent turnover and turmoil amongst the Teva leadership and Board”, “strategic confusion” and Teva’s under performance is “directly attributed to its “dysfunctional” culture”.  * The Board was described “like a Nuthouse” and ran the only CEO with pharmaceutical experience out of town within 18 months of being on the job  * “Do not wish to make Teva’s problems Mylan’s problems”  

Impressions: 5443

https://www.pharmacompass.com/radio-compass-blog/why-mylan-thinks-teva-s-shares-are-toilet-paper

#Phispers by PHARMACOMPASS
30 Apr 2015
Dr. Reddy’s expansion plans for API production
Unrelated to the inspection of the USFDA at the Dr. Reddys Srikakulam facility, Dr. Reddys sought permission from the Ministry of Environment, Forests & Climate Change to expand their drug and intermediate manufacturing at three locations. All three chemical technical operation (CTO) units, CTO-I, CTO-II & CTO-III are located in Medak district and the announced planned capacity increases along with the anticipated capital investment were   Existing Capacity Planned Capacity Anticipated Investment CTO I 14.7 TPM 45.5 TPM Rs 30 crores CTO II 21.9 TPM 68.9 TPM Rs 45 crores CTO - III 4.45 TPM 28.1 TPM Rs 12 crores  *$1 million is approximately about Rs 6.2 crores & TPM is tons per month In addition, the declaration given by Dr. Reddys also mentions the various products which will be produced at each facility (table below). Needless to say, the plans are ambitious however with the growth witnessed by the Indian pharmaceutical industry over the past decade, one can understand Dr. Reddys commitment to investing further in their business.   Table Dr. Reddys production plans at various facilities Product Name Planned Capacity (TPM) Facility Location Alendronate Sodium Trihydrate 6.67 CTO - III Alfuzosin 2.33 CTO - I Altretamine 0.03 CTO - I Amlodipine Besylate 33.33 CTO - II Amlodipine Besylate 133.33 CTO - III Amlodipine Besylate ( Ethyl 4 [2- (pthalamide)ethoxy] aceto acetate (TDM-2) 100 CTO - II Amlodipine Maleate 30 CTO - III Amsacrine 0.07 CTO - I Anastrazole 0.83 CTO - II Aprepitant 3.33 CTO - III Aripiprazole 0.33 CTO - II Atomoxetine 1.67 CTO - III Atorvastatin  375.83 CTO - II Azacitidine 0.67 CTO - I Bicalutamide 0.03 CTO - II Bivalirudin 0.03 CTO - II Bivalirudin Trifluoro Acetate 0.03 CTO - I Bortezomib 0.03 CTO - I Cabazitaxel 0.02 CTO - I Candesartan cilexetil 6.67 CTO - II Cetirizine Hydrochloride 66.67 CTO - I  Cetirizine 16.67 CTO - II Ciprofloxacin 176.67 CTO - II Ciprofloxacin HCl  533.33 CTO - II Ciprofloxacin Lactate 33.33 CTO - II Clopidogrel Bisulfate 500 CTO - I Clopidogrel Premix 166.67 CTO - II Diluted Everolimus 5% (Everolimus) 0.33 CTO - II Disodium Pamidronate 0.33 CTO - III Docetaxel 1.9 CTO - I Dutasteride 3.33 CTO - II Esomeprazole magnesium 66.67 CTO - III Ezetimibe 3.33 CTO - II Fexofenadine Hydrochloride  500 CTO - I Finasteride 10 CTO - II Fluoxetine 110 CTO - I Fondaparinux Sodium 0.33 CTO - II Galantamine 0.03 CTO - II Gemcitabine 13.33 CTO - I Glimepiride 13.33 CTO - II Imatinib 0.17 CTO - I Irinotecan 0.33 CTO - I Ketorolac 66.67 CTO - II Lacidipine 5 CTO - III Lamotrigine 33.33 CTO - I Lansoprozole 8.33 CTO - III Letrozole 0.03 CTO - II Levocetrizine Di HCl 10 CTO - III Levofloxacin 200 CTO - II Lomustine 1.33 CTO - I Losartan Postassium 150 CTO - I Meloxicam 0.03 CTO - I Memantine HCl 3.33 CTO - II Mesalamine 0.03 CTO - II Metoprolol Succinate 266.67 CTO - II Moxifloxacin 116.67 CTO - II Norfloxacin  0.03 CTO - I Omeprazole 133.33 CTO - III Omeprazole Magnesium 50 CTO - III Omeprazole Sodium 10 CTO - III Omerprazole Form B 33.33 CTO - III Paclitaxel 0.33 CTO - I Pantoprazole Sodium 100 CTO - III paroxetine HCl 0.03 CTO - II Pemetrexed 0.67 CTO - I Rabeprazole Sodium 83.33 CTO - III Raloxifene 33.33 CTO - II Ramipril 100 CTO - III Repaglinide 6.67 CTO - II Rivastigmine 6.67 CTO - II Risperidone 13.33 CTO - I Rivastigmine 6.667 CTO - I Rizatriptan Benzoate 1.33 CTO - II Rocuronium Bromide 0.03 CTO - II Ropinrole HCl 1.83 CTO - III Rosiglitazone 3.33 CTO - II Sparfloxacin 3.33 CTO - I Tacrolimus 5 CTO - II Tadalafil 3.33 CTO - II Telmisartan 100 CTO - II Temozolamide 0.03 CTO - I Terbinafine HCl 133.33 CTO - III Tizanidine HCl 16.67 CTO - III Topotecan 0.07 CTO - I valganciclovir 0.03 CTO - I Vardenafil 3.33 CTO - II Voriconazole 8.33 CTO - III Ziprasidone Hydrochloride 100 CTO - I Zoledronic acid 0.33 CTO - III Zolmitriptan 0.83 CTO - I Zonisamide 0.03 CTO - II

Impressions: 3087

https://www.pharmacompass.com/radio-compass-blog/dr-reddy-s-expansion-plans-for-api-production

#Phispers by PHARMACOMPASS
03 Apr 2015
Fondaparinux –An Opportunity Worth Developing
A recent study published in the Journal of the American Medical Association (JAMA) showed that patients who received the anticoagulant fondaparinux (Arixtra®) and had experienced a certain type of heart attack had a lower risk of major bleeding events and death, both in the hospital and after six months, compared to patients who received low-molecular-weight heparin (LMWH). The authors analyzed data from a Swedish registry, which included 40,616 patients who had experienced an NSTEMI (non-ST-segment elevation myocardial infarction). A certain pattern on an electrocardiogram following the heart attack was observed, and 14,791 patients (36.4 percent) received fondaparinux, while 25,825 (63.6 percent) received LMWH.  Fondaparinux, an injectable blood thinner that fights clots in the legs (deep vein thrombosis – DVT) and lungs (pulmonary embolism – PE), is a synthetic pentasaccharide, which is difficult to manufacture on a commercial scale.   Arixtra belonged to GSK as recently as 2013, when it was sold off to the South African company Aspen Global Incorporated. Due to Aspen’s lack of a sales representative in the US, they were forced to enter into a $300 million agreement with Mylan for the US market, through which Mylan would pay Aspen $225 million upon completion of the transaction, and an additional $75 million would be held in escrow until certain conditions were met. Apotex had previously been given the rights to sell the authorized generic of Arixtra, the rights of which would eventually transfer to Mylan, which was scheduled to occur by the end of 2014.  Arixtra and the authorized generic of Arixtra had US sales of approximately $18.8 million and $95.3 million, respectively, for the 12 months ending on June 30, 2014, according to IMS Health.  Currently, the only approved product on the US market, other than Mylan’s, is that of Dr. Reddy’s, which was approved in 2011. Dr. Reddy’s entered into a partnership with the Australian company Alchemia, who claims to have been granted patents over novel synthetic pathways that prevent others from using Alchemia’s proprietary process to manufacture fondaparinux until at least 2022.  The regulatory filing review on PharmaCompass shows two suppliers of the key intermediates who have submitted USDMFs, along with multiple API DMF fillings indicating increased availability of the drug substance. This should overcome a major barrier to entry into the Fondaparinux business.  What makes us believers in Fondaparinux? Here are some facts:  $150 million – This is the size of the market in the United States alone.  There are only 2 approved US marketing authorization holders (Mylan and Dr. Reddy’s).  There are alternative API supply sources emerging other than Aspen (through Sanofi’s Sisteron site and Alchemia). Blood thinners are a booming opportunity. Pfizer’s Eliquis, Bayer’s Xarelto, and Boehringer Ingelheim’s Pradaxa are all expected to achieve sales of more than $1 billion each. There has been limited development activity in India as demonstrated by the trade data. The high development costs will keep this market niche in the long run. The recently published study data is extremely positive and will increase sales.   

Impressions: 5027

https://www.pharmacompass.com/radio-compass-blog/fondaparinux-an-opportunity-worth-developing

#Phispers by PHARMACOMPASS
11 Mar 2015
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