FDA approves Roche's Kadcyla (trastuzumab emtansine), the first antibody-drug conjugate for treating HER2-positive metastatic breast cancer

FDA approves Roche's Kadcyla (trastuzumab emtansine), the first antibody-drug conjugate for treating HER2-positive metastatic breast cancer

Roche  announced that the U.S. Food and Drug Administration (FDA) has approved Kadcyla (trastuzumab emtansine or T-DM1) for the treatment of people with HER2-positive metastatic breast cancer (mBC) who have received prior treatment with Herceptin (trastuzumab) and a taxane chemotherapy. Kadcyla is the fourth medicine from Roche to receive FDA approval for people with advanced cancers within the past two years.

An antibody-drug conjugate (ADC) is a new kind of targeted cancer medicine that can attach to certain types of cancer cells and deliver chemotherapy directly to them. Kadcyla is the first FDA-approved ADC for treating HER2-positive mBC, an aggressive form of the disease.

"Kadcyla is an antibody-drug conjugate representing a completely new way to treat HER2-positive metastatic breast cancer, and it helped people in the EMILIA study live nearly six months longer," said Hal Barron, M.D., Roche's Chief Medical Officer and Head, Global Product Development. "We currently have more than 25 antibody-drug conjugates in our pipeline and hope this promising approach will help us deliver more medicines to fight other cancers in the future."

Kadcyla is made up of the antibody, trastuzumab, and the chemotherapy, DM1, joined together using a stable linker. Kadcyla combines the mechanisms of action of both trastuzumab and DM1, and it is the first Roche ADC approved by the FDA. Roche has studied ADC science for more than a decade and has eight ADCs in Phase I or Phase II studies for different types of cancer.

Roche has also submitted a Marketing Authorisation Application to other Regulatory Authorities around the world, including the European Medicines Agency (EMA), for Kadcyla for the treatment of people with HER2-positive mBC. This application is currently under review by the EMA.

About Kadcyla

Kadcyla is an ADC being studied in HER2-positive cancers. It is the first ADC to result from Roche and Genentech’s 30 years of HER2 pathway research and the third medicine Roche has developed for the treatment of HER2-positive breast cancer.

Like Herceptin, Kadcyla binds to HER2-positive cells and is thought to block out-of-control signals that make the cancer grow while also calling on the body's immune system to attack the cancer cells. Once Kadcyla is taken up by those cells, it is designed to destroy them by releasing the DM1 inside the cells.

Roche licenses technology for Kadcyla under an agreement with ImmunoGen, Inc.

About breast cancer

Breast cancer is the most common cancer among women worldwide.2 Each year about 1.4 million new cases of breast cancer are diagnosed worldwide, and over 450,000 women will die of the disease annually.In HER2-positive breast cancer, increased quantities of the human epidermal growth factor receptor 2 (HER2) are present on the surface of the tumour cells. This is known as "HER2 positivity" and affects approximately 15-20 percent of women with breast cancer HER2-positive cancer is a particularly aggressive form of breast cancer.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2011, Roche had over 80,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 42.2 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan.

Abbott to collaborate with Janssen and Pharmacyclics

Abbott to collaborate with Janssen and Pharmacyclics

      Abbott  announced that it will collaborate with Janssen Biotech, Inc. and Pharmacyclics, Inc. to explore the benefits of Abbott's proprietary FISH (fluorescence in situ hybridization) technology for use in developing a molecular companion diagnostic test to identify patients with a genetic subtype of chronic lymphocytic leukemia (CLL), the most common form of adult leukemia.

      Under the agreement, Abbott will develop a FISH-based test to identify high-risk CLL patients who have a deletion within a specific chromosome (chromosome 17p (del17p)) and may respond to ibrutinib, an oral, small molecule inhibitor of Bruton tyrosine kinase (BTK). Ibrutinib is currently in development by Janssen and Pharmacyclics for several B-cell malignancies, including chronic leukemia and lymphoma. Patients harboring a deletion within chromosome 17p are poor responders to chemoimmunotherapy and have limited treatment options. Having a test that is able to accurately detect the 17p deletion identifies a specific patient population with a high unmet medical need.

     "Like Abbott's other collaborations in the area of companion diagnostics, our goal is to leverage molecular technologies to help ensure that the right medicine is getting to the right person," said John Coulter, vice president, Molecular Diagnostics, Abbott. "Cancer is a complex disease where, historically, therapies have demonstrated only a 25 percent efficacy rate. Companion diagnostic tests can help improve these outcomes by selecting patients that are more likely to respond to specific therapies, reducing time to the most effective treatment and increasing the number of positive outcomes."

     In 2011, Abbott received U.S. Food and Drug Administration clearance for its Vysis CLL FISH Probe Kit. The kit targets multiple genes, including TP53 (tumor protein p53 gene, located on chromosome 17p) within the del17p region, and is used as an aid for determining prognosis for patients with CLL. Abbott's Vysis CLL FISH Probe Kit will be used for investigational use only to determine genetic marker status as part of the co-development efforts between Janssen, Pharmacyclics and Abbott.

About FISH

    FISH (fluorescence in-situ hybridization) technology has a variety of uses. It can identify whether too many, or too few, copies of a particular gene are present in the body's cells or whether certain genes have rearrangements that play an active role in disease progression. Since the technology works especially well for identifying genetic markers in solid tumors, cancer diagnostics are one of the fastest growing applications.

About Abbott Molecular

   Abbott Molecular is a leader in molecular diagnostics - the analysis of DNA and RNA at the molecular level. Abbott Molecular's tests can also detect subtle but key changes in patients' genes and chromosomes and have the potential to aid with early detection or diagnosis, can influence the selection of appropriate therapies, and may assist with monitoring of disease progression.

About Abbott

   Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 70,000.

   

Top 10 drugs of 2012 by sales in US Pharma....

Top 10 drugs of 2012 by sales in US Pharma....

TOP Pharma Companies of 2012...

TOP Pharma Companies of 2012...

5 Lessons from Coca Cola’s New Content Marketing Strategy

5 Lessons from Coca Cola’s New Content Marketing Strategy

Coca Cola has been part of popular culture for over 100 years and has been called a “Vision Brand“.

Its marketing and communication is purposeful and connects with its audience in a way that makes it stand out from its competitors.

Its mission is not about selling products but to create significant positive change in the world that makes the world a better place.

Coca Cola’s mission statement

• To refresh the world
• To inspire moments of optimism and happiness
• To create value and make a difference

Recently they have realised that their marketing strategy that has worked well for them for decades needed to evolve and as such they are moving from “Creative Excellence” to “Content  Excellence”

Creative excellence has always been at the heart of Coca Cola’s advertising and they have decided that content is now the key to marketing in the 21st century on a social web.

Content for Coca Cola is is now the “Matter” and “Substance” of “Brand Engagement”

So what can we learn from Coca Cola’s new marketing strategy?

Lesson 1: Create Liquid Content

The purpose of content excellence is to create “Ideas” so contagious that they cannot be controlled this is what is called “liquid content”.

On a social web people can easily share ideas, videos and photos on social networks such Facebook.

So create content that begs to be shared whether that be an image, a video or an article.

Lesson 2: Ensure your Content is Linked

The next part of the equation is to ensure that these ideas create content that is innately relevant to

• The business objectives of your company
• The brand
• Your customer interests

This is “Linked” content…. Content that is relevant and connected to the companies goals and brand.

Ensure that the content communicates your message that is congruent with your mission and values.

Lesson 3: Create Conversations

Coca Cola has realised that the consumer creates more stories and ideas than they do so the goal is provoke conversations and then “Act” and “React” to those conversations 365 days of the year.

The new “Distribution Technologies” of Twitter, YouTube and Facebook provide greater connectivity and consumer empowerment than ever before.

Don’t just publish but interact with your audience and tribe.

Lesson 4. Move onto Dynamic Story Telling

On traditional media in the past, story telling was static and a one way street. Television and newspapers shouted at you with no means of interaction.

Coca Cola has come the realisation that to grow their business on the social web they need to move on from “One Way Story Telling” to “Dynamic Story Telling”

This means you need to allow the story to evolve as you interact and converse with your customers. You need to converse with your customers in many media formats and social networks.

Storytelling has moved on from static and synchronous to multifaceted, engaged and spreadable.

Lesson 5: Be Brave and Creative with Your Content Creation

Part of the new Coca Cola content strategy is applying a 70/20/10 Investment principle to creating “Liquid content“.

• 70% of your content should be low risk. It pays the rent and is your bread and butter marketing (should be easy to do and only consumes 50% of your time)
• 20% of your content creation should innovate off what works.
• 10% of your content marketing is high risk ideas that will be tomorrows 70% or 20%…. be prepared to fail

This provides a blueprint regarding moving on from just developing white papers, to trying some content that is more visual, courageous and engaging in web world that has embraced multimedia and interactive content.

The 30 Second TV Ad is no Longer King

Coca Cola has come to the conclusion that the world has moved on from the 30 second TV ad. So has the the Old Spice brand and many other businesses who are embracing social media as part of their marketing strategy.

We need to move towards a genuine consumer collaboration model that builds buzz and adopts a more iterative approach to content creation.

Learning how to fuel the conversations, act and interact has never been more important.

Consumers ideas, creativity and conversations have been set free with the evolution of social networks, learning to leverage and wrangle those conversations to increase your brand visibility is now a vital part of your marketing.

Bristol-Myers Squibb enters a collaboration agreement with Reckitt Benckiser Group plc

Bristol-Myers Squibb enters a collaboration agreement with Reckitt Benckiser Group plc

(13-02-2013)
Bristol-Myers Squibb Company (NYSE: BMY) today announced it has entered into a three-year collaboration agreement with Reckitt Benckiser Group plc (LSE: RBL) for several of its over-the-counter medicines currently sold across Latin America, primarily in Mexico and Brazil.

Under the terms of the collaboration agreement, Reckitt Benckiser will pay Bristol-Myers Squibb an upfront payment in the amount of $438 million for the exclusive rights to sell, distribute and market the following medicines for a three-year period: Picot, an antacid, Tempra, a pain reliever and fever reducer, Micostatin, an antifungal, and Graneodin, a cough and cold medicine, sold primarily in Mexico; and Dermodex, an anti-rash cream, Luftal, an anti-gas medicine, and Naldecon, a cold and flu symptoms treatment, sold primarily in Brazil.

"As part of our BioPharma strategy, Bristol-Myers Squibb has worked to focus its businesses around the world on innovative medicines in areas of high unmet medical need," said Charles Bancroft, executive vice president, Intercontinental Region and Japan, and chief financial officer. "This agreement allows us to increase our focus on the launch and commercialization of our innovative portfolio in these important markets in Latin America."

During the collaboration term, Bristol-Myers Squibb will retain responsibility for manufacturing all of the products covered by the collaboration (either by itself or through third party manufacturers), and Reckitt Benckiser will purchase products from Bristol-Myers Squibb and pay royalties on product sales during the term of the collaboration.

Reckitt Benckiser will also pay to Bristol-Myers Squibb an option fee in the amount of $44 million for the right to purchase these products outright at the end of the three-year term, acquiring the sales, marketing, and distribution rights, along with assets related to the products, including the trademarks, remaining inventories, and certain other assets. Subject to certain rights it has to extend the term of the supply agreement with Bristol-Myers Squibb, Reckitt Benckiser would then assume all responsibility for the products. The purchase price will be based on average net sales during the two year period preceding the closing of the sale. No manufacturing facilities will be transferred from Bristol-Myers Squibb to Reckitt Benckiser Group plc as part of this transaction.

The transaction is subject to the satisfaction or waiver of customary closing conditions, including competition law authorizations in Brazil and Mexico.

Jefferies Group, Inc. acted as exclusive financial advisor to Bristol-Myers Squibb, and Kirkland & Ellis LLP acted as its legal adviser.

All Products of Pfizer(part-2)

All Products of Pfizer(part-2)

Brand Name

Neumega^®

(oprelvekin)

Neurontin^®

(gabapentin)

Nicotrol^® NS

(nicotine nasal spray)

Nicotrol^® Inhaler

(nicotine inhalation system)

Nitrostat^®

(nitroglycerin tablets, USP)

Norgestrel Ethinyl Estradiol

(norgestrel and ethinyl estradiol tablets)

Norpace^®

(disopyramide phosphate capsules)

Norvasc^®

(amlodipine besylate)

Ogen^™

(estropipate tablets, USP)

Ondansetron

(ondansetron for injection, USP)

Oxaliplatin

(oxaliplatin injection, USP)

Oxecta^™

(oxycodone HCl tablets, immediate-release)

Paclitaxel

(injection)

Pamidronate Disodium

(pamidronate disodium)

Paclitaxel Injection

(paclitaxel injection)

Pantoprazole Sodium

(delayed-release tablets)

Pediotic^® Suspension Sterile

(neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP)

Penicillin G Procaine

(penicillin G procaine injectable suspension)

Pfizerpen for Injection

(penicillin G potassium)

Phospholine Iodine^®

(echothiophate iodide for ophthalmic solution)

Pipracil^®

(piperacillin sodium)

Premarin^®

(conjugated estrogens)

Premphase^®

(conjugated estrogens plus medroxyprogesterone acetate tablets)

Prempro^®

(conjugated estrogens/medroxyprogesterone acetate tablets)

Preparation H^®

Prepidil^® Gel

(dinoprostone cervical gel)

Prevnar 13

(Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM₁₉₇ Protein])

Primatene^® Tablets

Pristiq^®

(desvenlafaxine) extended-release tablets

Procardia^®

(nifedipine)

Propranolol Hydrochloride

(propranolol hydrochloride extended-release capsules)

Prostin E2^®

(dinoprostone vaginal suppository)

Prostin VR Pediatric^®

(alprostadil injection, USP)

Protonix

(pantoprazole sodium)

Provera^®

(medroxyprogesterone acetate tablets, USP)

Quillivant™

(methylphenidate hydrochloride)

Rapamune

(sirolimus)

Rebif^®

(interferon beta-1a) sc injection

ReFacto^®

(Antihemophilic Factor [Recombinant])

Relistor

(methylnaltrexone bromide) subcutaneous injection

Relpax^®

(eletriptan HBr)

Revatio

(sildenafil) tablets

R-Gene^® 10

(10% arginine hydrochloride injection, USP)

Rifampin

(for injection, USP)

Robitussin^®

Septra^® Tablets

(trimethoprim and sulfamethoxazole)

Silvadene^® Cream 1%

(silver sulfadiazine)

Skelaxin^®

(metaxalone)

Solu-Cortef ^®

(hydrocortisone sodium succinate for injection, USP)

Solu-Medrol^®

(methylprednisolone sodium succinate for injection, USP)

Sonata^® CIV

(zaleplon)

Somavert^®

(pegvisomant for injection)

Spiriva^® HandiHaler^®

(tiotropium bromide inhalation powder)

Sutent^®

(sunitinib malate)

Synarel^®

(nafarelin acetate nasal solution)

Synercid^® I.V.

(quinupristin / dalfopristin for injection)

Tapazole^®

(methimazole tablets)

Tessalon^®

(100mg perles and 200mg capsules benzonatate, USP)

Thalitone^®

(chlorthalidone tablets)

ThermaCare^®

Thrombi-Gel^®

(thrombin / gelatin foam hemostat)

Thrombin-JMI^®

(thrombin, topical, bovine origin)

Thrombi-Pad^™

(3x3 hemostatic pad)

Tigan^®

(trimethobenzamide hydrochloride)

Tikosyn^®

(dofetilide)

Tilade^® Inhaler

(nedocromil sodium inhalation aerosol)

Tobramycin Injection, USP

Toposar^™

(etoposide injection, USP)

Topotecan

(topotecan hydrochloride for injection, USP)

Torisel^®

(temsirolimus) injection

Toviaz^™

(fesoterodine fumarate extended release tablets)

Trecator^®

(ethionamide tablets)

Trelstar™

(triptorelin pamoate for injectable suspension)

Trobicin^®

(spectinomycin for injectable suspension, USP)

Tussigon^®

(hydrocodone bitartrate and homatropine methylbromide)

Tygacil^®

(tigecycline)

Unasyn^®

(ampicillin sodium/sulbactam sodium)

Vancomycin

(sterile vancomycin hydrochloride)

Vecuronium Bromide

(vecuronium bromide for injection)

Venlafaxine Hydrochloride

(extended-release capsules)

Vfend^®

(voriconazole)

Viagra^®

(sildenafil citrate) tablets

Vibramycin^®

(doxycycline calcium, doxycycline hyclate, doxycycline monohydrate)

Vinorelbine

(vinorelbine injection)

Viracept^®

(nelfinavir mesylate)

Viroptic^®

(trifluridine ophthalmic solution)

Vistaril^®

(hydroxyzine pamoate)

Xalatan^®

(latanoprost ophthalmic solution)

Xalkori^®

(crizotinib)

Xeljanz

(tofacitnib)

Xanax^®

(alprazolam tablets)

Xyntha^®

(antihemophilic factor (recombinant), plasma/albumin-free)

Zaleplon

(capsules)

Zarontin^®

(ethosuximide capsules, USP and ethosuximide)

Zinecard^®

(dexrazoxane for injection)

Zithromax^®

(azithromycin)

Zmax^®

(azithromycin extended release) for oral suspension

Zoloft^®

(sertraline HCI)

Zosyn^®

(piperacillin and tazobactam for injection)

Zyvox^®

(linezolid)