An Overview Of Davens Inc Biology Essay

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Cancer is arguably the deadliest disorder to inflict mankind. Early stage Cancer detection is of the utmost importance, as it becomes virtually impossible to cure in its advanced stages of oncogenicity. Cancer Diagnosis can be done by various methods ranging from invasive to non-invasive methodologies. Nuclear diagnostic methods are the most reliable and widely used methods. SPECT and PECT are two such widely used methods for cancer detection and tumour visualisation. These methods are also used to test the efficacy of a particular anticancer therapy or drug. These methods use a radioisotope coupled with a ligand (specific for the tumour cells that we intend to detect), which is injected into a patient which in turn emits gamma rays (in SPECT) which in turn are detected and used to generate 2D/3D images using scanners.

We at Davens, have come up with two SPECT ligands, DPA 714 and RTFI, having broad spectrum functionalities. The ligands that are in use currently are mostly specific to a particular type of tumour cell/cancer type or at the most specific to only some of the cancer types. Our products advantage is that it can be used to detect a wide range of cancers. Lung, stomach, liver, colon and breast cancer cause the most cancer deaths each year and our ligands can detect all of them with great specificity.

Cancer is the leading cause of death worldwide: 7.9 million deaths (around 13% of all deaths) in 2007. Lung, stomach, liver, colon and breast cancer cause the most cancer deaths each year. Cancer deaths worldwide are projected at 12 million deaths in 2030.

When the cells of an organ or tissue in the body becomes abnormal, grows and multiplies out of control they usually form a mass called tumor and this particular state of formation of tumor is known as cancer.

When the normal cells maintains a life cycle where they reproduce and replace worn out tissue to maintain healthy organs, the cancer cells grows out of control and forms tumor. Some tumors grow and enlarge only at a particular tissue or organ where they begin and these types of tumors are referred as "Benign Tumors".

Cancer or Malignant tumors are the ones which not only enlarge locally where they have started but also possess the potential to spread, invade and destroy other body parts, tissues and organs.

Different types of cancer vary in their signs and symptoms, how fast they grow how they spread and how they react to different treatments. This is why it is important to diagnose a cancer quickly and accurately to begin specialized treatments.

Many genes in the human body help to control the division and growth of our cells. When changes (mutations) occur in those genes, a cell may lose control. Over a time, a number of gene mutations may occur in a cell, allowing it to divide and grow in a way that becomes cancer. Since most cancers do not happen until a cell is affected by several gene mutations, most cancers are not seen until later in life.

Most cancers occur by chance in people aging 50 or older since there is an increase in number of possible cancer causing mutations in our DNA which makes age an important risk factor for cancer.

Metastasis is nothing but how the cancer spreads to the other body parts from one organ or a part of the body. Metastases take place through the lymphatic system, through the blood. Cancers may spread through more than a single route and they are as follows:

Cancer prevalence is the total number of people living with cancer at any point of time which includes people diagnosed with cancer in the past and recently diagnosed.

DIAGNOSTIC METHODS USED:

Early detection of cancer can greatly improve the likelihood of successful treatment and survival. Physicians use the following to diagnose cancer.

New generation SPECT (single photon emission computed tomography) imaging which is set to revolutionize the medical imaging process, aims at improving the future diagnosis of cancer and the probability of successful cancer therapy whilst enabling a higher throughput of patients in hospitals.

Figure- , Gamma camera images at 72 h of patient with T3N0M0 squamous cell cancer of the tongue base (patient 14). A, whole body gamma camera scan revealing tongue base tumor (Tu), cardiac blood pool (CP), liver (L), and spleen (Spl). In addition, radioactivity localized to the bowel is seen. B, sagittal SPECT image. C, coronal SPECT image. D, transverse SPECT image. Courtesy : Clinical Cancer Research February 2001 vol. 7 no. 2 243-254

SPECT detects gamma rays emitted by a tiny amount of radioactive pharmaceutical that is injected into the body. SPECT is widely used method to test the functioning of the heart and detection of tumours.

The basic technique requires injection of a gamma-emitting radioisotope (also called radionuclide) into the bloodstream of the patient. Occasionally the radioisotope is a simple soluble dissolved ion, such as a radioisotope of gallium (III), which happens to also have chemical properties which allow it to be concentrated in ways of medical interest for disease detection. However, most of the time in SPECT, a marker radioisotope, which is of interest only for its radioactive properties, has been attached to a special radioligand, which is of interest for its chemical binding properties to certain types of tissues. This marriage allows the combination of ligand and radioisotope (the radiopharmaceutical) to be carried and bound to a place of interest in the body, which then (due to the gamma-emission of the isotope) allows the ligand concentration to be seen by a gamma-camera.

SPECT is similar to PET in its use of radioactive tracer material and detection of gamma rays. In contrast with PET, however, the tracer used in SPECT emits gamma radiation that is measured directly, whereas PET tracer emits positrons which annihilate with electrons up to a few millimeters away, causing two gamma photons to be emitted in opposite directions. A PET scanner detects these emissions "coincident" in time, which provides more radiation event localization information and thus higher resolution images than SPECT (which has about 1cm resolution). SPECT scans, however, are significantly less expensive than PET scans, in part because they are able to use longer-lived more easily-obtained radioisotopes than PET.

SPECT can be used to complement any gamma imaging study, where a true 3D representation can be helpful. E.g. tumour imaging, infection (leukocyte) imaging, thyroid imaging or bone imaging.

Because SPECT permits accurate localisation in 3D space, it can be used to provide information about localised function in internal organs, such as functional cardiac or brain imaging.

OUR PRODUCT:

Our product is the ligand that is coupled with the radioisotope for use in a SPECT procedure. Our product portfolio consists of two ligands, DPA-714 & RTFI-1 along with a bifunctional chelator for ease of coupling with the cheapest and widely used radioisotope, 99m Tc (Technetium 99m).

Our ligands DPA -714 & RTFI-1 bind to TSPO (translocator protein) & σ2 receptors respectively which are abundantly over expressed in most cancer cells. These ligands are highly specific and bind to their respective receptors and gamma rays are released by the linked radioisotope.

SPECT MARKET ANALYSIS:

SPECT and PET procedures have become the mainstay of cancer diagnosis. These cutting edge technologies can provide real time imaging of the tumour and the efficacy of a treatment that is underway against it.

In 2008 alone, 16 million SPECT scans were performed worldwide and is expected to increase further as the technology becomes available to hospitals in Developing countries. In the USA, sales of radiopharmaceuticals for performing such scans in nuclear medicine reached $1.16 billion in the year 2009.

As mentioned earlier, a SPECT procedure is cheaper than a PET scan procedure and can cost $1000 on an average in the USA.

We are currently looking at the US market for rolling out our product. In the US, deaths from Cancer are projected to overtake cardiac and cerebrovascular related fatalities in the near future. Worldwide cancer fatalities are projected touch 12 million in 2030, according to a conservative estimate by WHO.

Lung, Colon, Stomach, Liver and Breast cancers are the leading types of cancers and our products can detect these cancers with high level of specificity. Our products can also be used to detect Glial carcinomas. Whilst, ligands from our competitors are rarely broad spectrum, i.e. most can detect a limited number of cancers.

COMPETITORS:

MDS Nordion and GE Healthcare/Amersham International are currently the world's leading producers of radioligands. MDS Nordion's main focus is Europe and relies on its vast supply chain network to deliver its product i.e. ligands labelled with radioisotopes in-house at its manufacturing facility.

Our Differential advantage is that our ligands can be used to detect a wide range of cancers and that we also provide a Bifunctional chelator for coupling with 99m Tc. The radioisotope 99m Tc has a half life of 6 hours compared to that of 18F, which has a short half life of 110 mins. 18F, which is the mainstay of the current competitors portfolios requires carefully managed supply chain models with tight deadlines and hence the coupling is done inhouse. But, in the case of 99m Tc, ligands coupled with the chelator can be freeze dried and transported to the hospitals without any tight deadlines. Moreover, with Technetium generators in place, it is relatively cheaper to generate the 99m Tc radioisotope in the main medical facilities.

INTELLECTUAL PROPERTY:

Our IP lies in the combination of the bifunctional chelator coupled with our ligands. Due diligence has been paid for prior art work using professional service providers. We have filed a utility patent in the US patent office at California. We are looking at an approval timeline of approximately 30 months.

MANUFACTURING:

Our strategy is to subcontract all of the manufacturing processes to renowned contract manufacturing organizations. Potential candidates include Abbott and Bayer. The chemical formulations that have not been included in this report will be provided to them with detailed process parameters that have to be followed. Our product due to its synthetic nature will not require complex scale up prerequisites. The main reasons behind this decision to outsource are quality, timelines and cost.

Our product is the ligand that is coupled to the chelator and freeze dried. Our final product will be in the form of kits with ten vials in each of them. Each vial would contain the following,

The steps involved in the final formulation are,

• Weighing and dissolution of SnCl2 in dilute HCl

• Weighing and dissolution of the ligand

• Adding the required SnCl2 solution to ligand solution with constant stirring

• Adjustment of the pH

• Sterile filtering through membrane filters

• Dispensing into sterile vials

• Freeze drying

• Packaging

For ease of planning, we have staged our whole Gantt chart into three stages. Stage 1 encompasses the initial R&D, GMP pilot scale manufacture and the patenting process. Stages 2 and 3 are the critical stages with important processes like the regulatory approval process, manufacturing etc that are scheduled to take place at that point of time.

FINANCIAL DATA AND COSTING:

The costing and financial data have been drawn up with accordance to established guidelines and requirements.

INVESTMENT REQUIRED

Total investment required over all the three stages is $98.5 million. For this amount of investment we are ready to offer a sizeable stake in the company. Our initial offer is 30% pending further negotiations.

Prior Market research is to be carried out before product launch using renowned market research companies.

PROMOTION:

· Conferences: Medical conferences on Cancer diagnosis

· Advertorials: Articles in leading Medical Journals

· Case Studies: Analysis of product by leading Oncologists and Academics

· Medical Blogs

· Provide free samples to Clinics

Our principle targets would be the Oncologists and Radiologists in central medical facilities.

We are looking at pricing a ten vial kit at $4000 and would be flexible with the pricing awaiting further market research data.

OUR TEAM:

CHIEF EXECUTIVE OFFICER: Mr. Varun Venkatachalam ( B.Tech, MBA)

Primary roles:

· Managing company growth and strategy

· Raise funding

· Liaison with Investors

· Look for strategic partnerships

Mr. Venkatachalam has an engineering background in Biotechnology. He has worked in management positions in many companies, thus bringing with him a vast amount of professional experience. He was also involved in two start-up companies that have been fairly successful.

MANAGING DIRECTOR: Mr. Nabeel Hassim (B.E., MBA)

Primary roles:

· Executive responsibility

· Day to day operations in charge

· Short term strategic decision making in consultation with the CEO

· Reporting head for all the departmental heads

Mr. Hassim has an engineering background in the food industry. He has worked at various capacities in giant food corporations.

CHIEF FINANCIAL OFFICER: Dr. Thirayan Thambu (Msc, PhD)

Primary roles:

· Financial strategic decision making point person

· Setting long term and short term financial goals

· Day to day financial management

· Budgeting and fund utilisation

CHIEF SCIENTIFIC OFFICER: Dr. Aditi Nohria (Msc, PhD)

Primary roles:

· Incharge of the R&D department

· Planning and execution of all technical product testing

· Driving new technology development

SENIOR MANAGER (SALES&MARKETING): Mr. Satrajit Chakraborty (Msc, MBA)

Primary roles:

· Head of sales and marketing division

· Responsible for marketing strategies

· Responsible for managing sales and distribution network

PRINCIPAL SCIENTIST: Dr. Deepika Chopra (Msc, PhD)

Primary roles

· Assist CSO in managing the R&D department

· Head a team of talented scientist responsible for new product development

· Responsible for QC and QA testing parameters

The company is a wholly owned entity belonging to the management described above. Each of the above mentioned members of the company's management owns an equal share.

Our immediate strategy is to look for potential collaborators who would be interested in licensing out our products in different geographical regions, since we are looking at launching the product only in the US. The licensing period should be atleast for a minimum duration of 5 years.

Our ultimate strategy is to sell the company to the highest bidder and exit.

To conclude, we would like to emphasise on the fact that incidence of cancer is projected to rise drastically and the importance of diagnostic imaging would be unfathomable. At present, nuclear medicine is fast emerging as the mainstay for cancer diagnosis with huge future potential in other areas of medicine too.

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